Large

Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We advance our mission to alleviate pain and improve the quality of life for patients around the world with our innovative products and suite of integrated digital and robotic technologies leverage data, data analytics and artificial intelligence. Founded in 1927 and based in Warsaw, Zimmer Biomet has operations in more than 25 countries and sales in more than 100 countries. We maintain world-class scientific facilities and resources and collaborate with leading clinicians and researchers around the world.

Manufacturing & Electronics

Zimmer Biomet

Manufacturing

You need a Law or Economics degree, 7+ years in Legal/Compliance, MedTech experience, advanced Microsoft 365 and PowerBI skills, plus strong English communication. Additional languages are a plus.

You will manage compliance strategy execution, analyze audits, lead program improvements, oversee AuditBoard data integrity, and coordinate policy governance and vendor interactions.

<div>
 <p>At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.</p>
 <p></p>
 <p><br> As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.</p>
 <div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> What You Can Expect</b></h2> 
   </div>
   <div>
    <p> The Global Compliance Associate Director will oversee the execution of the Compliance Program Strategy and Sustainability Plan. This includes preparing periodic reports for executive leadership and the Audit Committee/Board. The position will also oversee and manage the continuous improvement protocol to enhance the effectiveness and efficiency of the Compliance Program. Additionally, the position will serve as a system administrator for AuditBoard, ensuring data integrity, managing platform enhancements, and promoting best practices across Compliance teams.<br> This position will report to the Director Global Compliance Operations.<br> This position has flexibility to work from any location</p>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> How You'll Create Impact</b></h2> 
   </div>
   <div>
    <ul>
     <li>Manage execution of the Compliance Program Strategy and Sustainability Plan, including preparing the periodic reporting to executive leadership and the Audit Committee/Board under the supervision of the Director Global Compliance Operations.</li>
     <li>Analyze findings and trends arising from compliance and internal audits, monitoring activities, and investigations and support implementing global initiatives to address identified gaps and improvement opportunities; work with the global compliance functions and other key functional stakeholders to get alignment on Compliance Program improvements.</li>
     <li>Manage the continuous improvement protocol, including the periodic assessment and benchmarking of the Corporate Compliance Program using internal and/or external resources.</li>
     <li>Lead or support compliance program improvements and other global compliance projects as directed by the Director Global Compliance Operations.</li>
     <li>Act as a system admin for AuditBoard (software used to track compliance related issues and remediations) to ensure data integrity and consistency as well as manage the continous enhancements of the platform to increase efficiencies throughout the Compliance organization and sharing of best practices across AuditBoard users.</li>
     <li>Lead policy governance process, may supervise and coordinate policy exceptions, translations, and vendor coordination</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> What Makes You Stand Out</b></h2> 
   </div>
   <div>
    <ul>
     <li>Compliance Acumen: Demonstrates a strong understanding of elements essential for an effective compliance program and the global operationalization of compliance programs. Has familiarity with relevant laws impacting U.S.-based multinational corporations, such as the U.S. Foreign Corrupt Practices Act.</li>
     <li>Analytical Thinking and Adaptability: Organized and detail-oriented. Upholds a high degree of professionalism, ethics, and integrity.</li>
     <li>Data-Driven Decision Making: Proficient in working with data from reports and analytics. Utilizes data to set focus areas and enhance decision-making processes. Experience in visualizing data through presentations and dashboards.</li>
     <li>Communication Skills &amp; Work Style: Collaborates effectively with peers within the global Compliance team. Communicates adeptly to diverse audiences using various formats (presentations, written proposals, etc.). Self-motivated, meets strict deadlines, and maintains a positive, can-do attitude and shows enthusiasm.</li>
     <li>Cultural Competency: Actively contributes to an inclusive workplace that empowers individuals and leverages diverse perspectives. Demonstrates awareness of cultural norms and operates both independently and as part of a team. Builds relationships across and beyond the organization.</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> Your Background</b></h2> 
   </div>
   <div>
    <ul>
     <li>Educational Background: Holds a Bachelor of Law or Economics degree or an equivalent qualification in Legal, Compliance, Audit or related fields.</li>
     <li>Professional Experience: Brings at least 7 years of relevant work experience in Legal, Compliance, Audit or related areas, and experience within the MedTech sector or in related healthcare industries (e.g., pharmaceuticals, biotechnology, or other life sciences).</li>
     <li>Technical Skills: Possesses advanced to expert proficiency in working with basic Microsoft 365 applications such as PowerPoint, Excel and Word to analyze data and produce reports. Advanced proficiency using PowerBI or similar data visualization and analytics tools (Tableau, Smartsheet etc.). Knowledge of AuditBoard is considered an advantage.</li>
     <li>English: Must have excellent verbal and written communication skills in English.</li>
     <li>Additional languages are considered an advantage.</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> Travel Expectations</b></h2> 
   </div>
   <div>
    <ul>
     <li>Workplace: This position has flexibility to work from any location.</li>
     <li>Travel: As and when needed; less than 10%</li>
    </ul>
   </div>
  </div>
 </div>
 <p><br> EOE/M/F/Vet/Disability</p>
</div>


 At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
 
  As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
 
  
   
     What You Can Expect 
   
   
     The Global Compliance Associate Director will oversee the execution of the Compliance Program Strategy and Sustainability Plan. This includes preparing periodic reports for executive leadership and the Audit Committee/Board. The position will also oversee and manage the continuous improvement protocol to enhance the effectiveness and efficiency of the Compliance Program. Additionally, the position will serve as a system administrator for AuditBoard, ensuring data integrity, managing platform enhancements, and promoting best practices across Compliance teams. This position will report to the Director Global Compliance Operations. This position has flexibility to work from any location
   
  
  
   
     How You'll Create Impact 
   
   
    
     Manage execution of the Compliance Program Strategy and Sustainability Plan, including preparing the periodic reporting to executive leadership and the Audit Committee/Board under the supervision of the Director Global Compliance Operations.
     Analyze findings and trends arising from compliance and internal audits, monitoring activities, and investigations and support implementing global initiatives to address identified gaps and improvement opportunities; work with the global compliance functions and other key functional stakeholders to get alignment on Compliance Program improvements.
     Manage the continuous improvement protocol, including the periodic assessment and benchmarking of the Corporate Compliance Program using internal and/or external resources.
     Lead or support compliance program improvements and other global compliance projects as directed by the Director Global Compliance Operations.
     Act as a system admin for AuditBoard (software used to track compliance related issues and remediations) to ensure data integrity and consistency as well as manage the continous enhancements of the platform to increase efficiencies throughout the Compliance organization and sharing of best practices across AuditBoard users.
     Lead policy governance process, may supervise and coordinate policy exceptions, translations, and vendor coordination
    
   
  
  
   
     What Makes You Stand Out 
   
   
    
     Compliance Acumen: Demonstrates a strong understanding of elements essential for an effective compliance program and the global operationalization of compliance programs. Has familiarity with relevant laws impacting U.S.-based multinational corporations, such as the U.S. Foreign Corrupt Practices Act.
     Analytical Thinking and Adaptability: Organized and detail-oriented. Upholds a high degree of professionalism, ethics, and integrity.
     Data-Driven Decision Making: Proficient in working with data from reports and analytics. Utilizes data to set focus areas and enhance decision-making processes. Experience in visualizing data through presentations and dashboards.
     Communication Skills & Work Style: Collaborates effectively with peers within the global Compliance team. Communicates adeptly to diverse audiences using various formats (presentations, written proposals, etc.). Self-motivated, meets strict deadlines, and maintains a positive, can-do attitude and shows enthusiasm.
     Cultural Competency: Actively contributes to an inclusive workplace that empowers individuals and leverages diverse perspectives. Demonstrates awareness of cultural norms and operates both independently and as part of a team. Builds relationships across and beyond the organization.
    
   
  
  
   
     Your Background 
   
   
    
     Educational Background: Holds a Bachelor of Law or Economics degree or an equivalent qualification in Legal, Compliance, Audit or related fields.
     Professional Experience: Brings at least 7 years of relevant work experience in Legal, Compliance, Audit or related areas, and experience within the MedTech sector or in related healthcare industries (e.g., pharmaceuticals, biotechnology, or other life sciences).
     Technical Skills: Possesses advanced to expert proficiency in working with basic Microsoft 365 applications such as PowerPoint, Excel and Word to analyze data and produce reports. Advanced proficiency using PowerBI or similar data visualization and analytics tools (Tableau, Smartsheet etc.). Knowledge of AuditBoard is considered an advantage.
     English: Must have excellent verbal and written communication skills in English.
     Additional languages are considered an advantage.
    
   
  
  
   
     Travel Expectations 
   
   
    
     Workplace: This position has flexibility to work from any location.
     Travel: As and when needed; less than 10%
    
   
  
 
  EOE/M/F/Vet/Disability


Global Compliance Associate Director - Zimmer Biomet

Germany

United Kingdom

Canada

United States

Ireland

Global Compliance Associate Director

You need a recognized accountancy qualification, 5+ years in cost accounting, strong Excel skills, and experience with JD Edwards. Must be detail-oriented, proactive, and results-driven.

You will analyze financial data, support budget preparation, ensure compliance, monitor capital investments, lead finance projects, and drive continuous improvement while maintaining internal controls.

Galway

<div>
 <p>At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.</p>
 <p></p>
 <p><br> As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.</p>
 <div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> What You Can Expect</b></h2> 
   </div>
   <div>
    <p> As Senior Finance Analyst to two Manufacturing Sites in Ireland you will provide support to the management team. <br> Providing a monthly analysis of actual v budget &amp; projected spend and other reports of key financial data. </p>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b>How You'll Create Impact</b></h2> 
   </div>
   <div>
    <ul>
     <li>Senior Finance Analyst to two Manufacturing Sites.</li>
     <li> Provide support to the management team via providing a monthly analysis of actual – v – budget &amp; projected spend and other reports of key financial data. </li>
     <li>Make recommendations to management to drive business performance and ensure focus is to continually control the cost base of the facilities</li>
     <li> Provide financial and analytical support to business partners for key projects or productivity/cost savings initiatives</li>
     <li> Preparation of Opex &amp; Capex for Budgets and Projections</li>
     <li> Ensure key business and financial processes (eg Inventory, Capital, GL etc) are implemented in an efficient and timely manner. </li>
     <li>Ensure all corporate and project timelines are met</li>
     <li> Ensure Capital Investment is monitored and accurately recorded</li>
     <li> Preparation &amp; Review of Month End accounts &amp; Balance Sheet Reconciliations for area of responsibility. Ensure accuracy of the General Ledger and other financial data</li>
     <li> Ensure compliance with corporate/local policies and control procedures. Implement &amp; maintain strong internal controls within the plants to ensure excellent audit results – Internal, External &amp; Sox.</li>
     <li> Lead key finance projects including transformation, process and system upgrades and other business requirements</li>
     <li> Actively seek to implement continuous improvement in area of responsibility</li>
     <li> Other accounting duties as and when needed</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> What Makes You Stand Out</b></h2> 
   </div>
   <div>
    <ul>
     <li>Highly motivated, self starter willing to meet strict deadlines and time constraints.</li>
     <li> Able to work with minimal supervision, while maintaining the balance of keeping the Finance Lead informed on relevant issues</li>
     <li> Results and performance driven</li>
     <li> Must demonstrate ability to work well in a dynamic, global organization environment.</li>
     <li> Excellent attention to detail and analytical skills. </li>
     <li>Good problem-solving skills.</li>
     <li> Proactive, enthusiastic attitude to work and committed to continuous process improvement</li>
     <li> Ability to clearly and concisely communicate financial matters to business partners.</li>
     <li> Demonstrates characteristics of high potential for future developmental opportunities.</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> Your Background</b></h2> 
   </div>
   <div>
    <ul>
     <li>Recognised Accountancy qualification. </li>
     <li>5+ years PQE in management/cost accounting, in a manufacturing environment (preferably a US multinational)</li>
     <li> Excellent working knowledge of standard costing and inventory transactions</li>
     <li> High degree of computer literacy</li>
     <li> Experience of working with integrated business systems (preferably JD Edwards)</li>
     <li> Experience working with Hyperion would be advantageous. </li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b>Travel Expectations</b></h2>
   </div>
  </div>
 </div>
 <div></div>
 <p><br> EOE/M/F/Vet/Disability</p>
</div>


 At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
 
  As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
 
  
   
     What You Can Expect 
   
   
     As Senior Finance Analyst to two Manufacturing Sites in Ireland you will provide support to the management team.  Providing a monthly analysis of actual v budget & projected spend and other reports of key financial data. 
   
  
  
   
    How You'll Create Impact 
   
   
    
     Senior Finance Analyst to two Manufacturing Sites.
      Provide support to the management team via providing a monthly analysis of actual – v – budget & projected spend and other reports of key financial data. 
     Make recommendations to management to drive business performance and ensure focus is to continually control the cost base of the facilities
      Provide financial and analytical support to business partners for key projects or productivity/cost savings initiatives
      Preparation of Opex & Capex for Budgets and Projections
      Ensure key business and financial processes (eg Inventory, Capital, GL etc) are implemented in an efficient and timely manner. 
     Ensure all corporate and project timelines are met
      Ensure Capital Investment is monitored and accurately recorded
      Preparation & Review of Month End accounts & Balance Sheet Reconciliations for area of responsibility. Ensure accuracy of the General Ledger and other financial data
      Ensure compliance with corporate/local policies and control procedures. Implement & maintain strong internal controls within the plants to ensure excellent audit results – Internal, External & Sox.
      Lead key finance projects including transformation, process and system upgrades and other business requirements
      Actively seek to implement continuous improvement in area of responsibility
      Other accounting duties as and when needed
    
   
  
  
   
     What Makes You Stand Out 
   
   
    
     Highly motivated, self starter willing to meet strict deadlines and time constraints.
      Able to work with minimal supervision, while maintaining the balance of keeping the Finance Lead informed on relevant issues
      Results and performance driven
      Must demonstrate ability to work well in a dynamic, global organization environment.
      Excellent attention to detail and analytical skills. 
     Good problem-solving skills.
      Proactive, enthusiastic attitude to work and committed to continuous process improvement
      Ability to clearly and concisely communicate financial matters to business partners.
      Demonstrates characteristics of high potential for future developmental opportunities.
    
   
  
  
   
     Your Background 
   
   
    
     Recognised Accountancy qualification. 
     5+ years PQE in management/cost accounting, in a manufacturing environment (preferably a US multinational)
      Excellent working knowledge of standard costing and inventory transactions
      High degree of computer literacy
      Experience of working with integrated business systems (preferably JD Edwards)
      Experience working with Hyperion would be advantageous. 
    
   
  
  
   
    Travel Expectations
   
  
 
 
  EOE/M/F/Vet/Disability


Senior Finance Analyst - Zimmer Biomet

Zimmer Ortho Mfg Ltd

Senior Finance Analyst

You need 5+ years in medical device regulatory affairs, experience with Class III devices, strong writing and computer skills, knowledge of US/EU regulations, and the ability to manage multiple projects.

You will manage regulatory submissions, ensure compliance, write justifications, support product changes, and guide junior team members while maintaining regulatory information systems.

<div>
 <p>At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.</p>
 <p></p>
 <p><br> As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.</p>
 <p></p>
 <div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> What You Can Expect</b></h2>
   </div>
   <p></p>
   <div>
    <p><br> As a Senior Regulatory Affairs Specialist you will be responsible for the development and execution of regulatory strategies activities to support the tasks assigned to the Global Knee Manufacturing Regulatory Affairs team.</p>
    <p><br> </p>
    <p>You will provide advice on regulatory requirements to support manufacturing changes, cost saving initiatives, supplier change notifications and manufacturing transfers across the Zimmer Biomet manufacturing network. You will prepare submissions and negotiate their approval with relevant regulatory authorities. You will also assist with the regulatory license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audits, and maintain manufacturing site registrations.</p>
    <p><br> </p>
    <p>You will follow Zimmer Biomet corporate policies for maintaining approval of medical device products as part of the Global Knee Manufacturing Regulatory Affairs team.</p>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> How You'll Create Impact</b></h2>
   </div>
   <p></p>
   <div>
    <br> 
    <ul>
     <li> Maintain Zimmer Biomet regulatory approvals and ensure compliance with all applicable regulations</li>
     <li> Responsible for coordinating the planning, preparation, assembly, and review of regulatory submissions to the FDA, Notified Bodies and other worldwide government agencies as required to ensure timely approval for market release. Able to write regulatory justifications to support submission filing decisions</li>
     <li> Prepare FDA regulatory submissions including US Class III 30 Day Notices and US Class II 510(k)submissions as applicable for product changes/Transfers</li>
     <li> Prepare Change Notifications and submissions to EU Notified Bodies for Zimmer Biomet products</li>
     <li> Prepare dossiers for registration of products in countries outside the U.S and EU</li>
     <li> Support value improvement engineering teams on possible regulatory impact of proposed changes during project initiation and implementation</li>
     <li> Apply FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization</li>
     <li> Work with international Zimmer Biomet regulatory staff and technical experts to resolve potential regulatory issues and questions from regulatory agencies</li>
     <li> Provide support, training and guidance to junior RA team members</li>
     <li> Establish and maintain regulatory information systems both electronically and hard copy</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> What Makes You Stand Out</b></h2>
   </div>
   <p></p>
   <div>
    <p><b><br> Professional experience:</b></p>
    <ul>
     <li> Minimum of five years’ experience in medical device regulatory affairs</li>
     <li> Experience with US Class III medical devices (PMA) preferred</li>
     <li> Strong computer skills</li>
    </ul>
    <p></p>
    <p><b><br> Special expertise:</b></p>
    <ul>
     <li> Strong knowledge of EU and US medical device regulations
      <ul>
       <li> Submissions types to the U.S. FDA and EU Notified Bodies</li>
       <li> Experience with in assessing medical device changes</li>
      </ul></li>
     <li> Ability to stay abreast of regulations pertinent to medical devices</li>
     <li> Ability to identify and assess business risks for a given regulatory strategy</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> Your Background</b></h2>
   </div>
   <p></p>
   <div>
    <p><b><br> Education:</b></p>
    <ul>
     <li> Bachelor’s Degree (4-year university degree) life sciences, technical (engineering), quality or related field required with advanced degree preferred</li>
     <li> Education in Medical Device Regulatory Affairs is a plus</li>
     <li> A combination of education and experience may be considered</li>
    </ul>
    <p></p>
    <p><b><br> Personal skills requirements:</b></p>
    <ul>
     <li> Demonstrated technical writing and communication skills</li>
     <li> Strong attention to details</li>
     <li> Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines</li>
     <li> Ability to function well as a member of the team and build relationships between regulatory affairs and other areas of the organization</li>
    </ul>
   </div>
  </div>
 </div>
 <p><br> EOE/M/F/Vet/Disability</p>
</div>


 At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
 
  As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
 
 
  
   
     What You Can Expect
   
   
   
     As a Senior Regulatory Affairs Specialist you will be responsible for the development and execution of regulatory strategies activities to support the tasks assigned to the Global Knee Manufacturing Regulatory Affairs team.
     
    You will provide advice on regulatory requirements to support manufacturing changes, cost saving initiatives, supplier change notifications and manufacturing transfers across the Zimmer Biomet manufacturing network. You will prepare submissions and negotiate their approval with relevant regulatory authorities. You will also assist with the regulatory license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audits, and maintain manufacturing site registrations.
     
    You will follow Zimmer Biomet corporate policies for maintaining approval of medical device products as part of the Global Knee Manufacturing Regulatory Affairs team.
   
  
  
   
     How You'll Create Impact
   
   
   
     
    
      Maintain Zimmer Biomet regulatory approvals and ensure compliance with all applicable regulations
      Responsible for coordinating the planning, preparation, assembly, and review of regulatory submissions to the FDA, Notified Bodies and other worldwide government agencies as required to ensure timely approval for market release. Able to write regulatory justifications to support submission filing decisions
      Prepare FDA regulatory submissions including US Class III 30 Day Notices and US Class II 510(k)submissions as applicable for product changes/Transfers
      Prepare Change Notifications and submissions to EU Notified Bodies for Zimmer Biomet products
      Prepare dossiers for registration of products in countries outside the U.S and EU
      Support value improvement engineering teams on possible regulatory impact of proposed changes during project initiation and implementation
      Apply FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization
      Work with international Zimmer Biomet regulatory staff and technical experts to resolve potential regulatory issues and questions from regulatory agencies
      Provide support, training and guidance to junior RA team members
      Establish and maintain regulatory information systems both electronically and hard copy
    
   
  
  
   
     What Makes You Stand Out
   
   
   
     Professional experience:
    
      Minimum of five years’ experience in medical device regulatory affairs
      Experience with US Class III medical devices (PMA) preferred
      Strong computer skills
    
    
     Special expertise:
    
      Strong knowledge of EU and US medical device regulations
      
        Submissions types to the U.S. FDA and EU Notified Bodies
        Experience with in assessing medical device changes
      
      Ability to stay abreast of regulations pertinent to medical devices
      Ability to identify and assess business risks for a given regulatory strategy
    
   
  
  
   
     Your Background
   
   
   
     Education:
    
      Bachelor’s Degree (4-year university degree) life sciences, technical (engineering), quality or related field required with advanced degree preferred
      Education in Medical Device Regulatory Affairs is a plus
      A combination of education and experience may be considered
    
    
     Personal skills requirements:
    
      Demonstrated technical writing and communication skills
      Strong attention to details
      Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
      Ability to function well as a member of the team and build relationships between regulatory affairs and other areas of the organization
    
   
  
 
  EOE/M/F/Vet/Disability


Senior Regulatory Affairs Specialist - Zimmer Biomet

Senior Regulatory Affairs Specialist

You need a relevant degree, 3-4 years in a supervisory role in manufacturing, strong people management, lean process improvement experience, and knowledge of GMP/FDA regulations.

You will supervise production teams, ensure quality and delivery targets, manage employee performance, facilitate communication, lead problem-solving, drive continuous improvement, and uphold safety compliance.

<div>
 <p>At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.</p>
 <p></p>
 <p><br> As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.</p>
 <div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> What You Can Expect</b></h2> 
   </div>
   <div>
    <p> The Product Supervisor has overall responsibility for a Product Builder group in meeting its requirements in terms of Quality, Cost, Delivery, Supply, Safety and People. Strong communication, leadership and organizational skills are essential as well as a full understanding of the manufacturing process. Leads lean-manufacturing, productivity and quality- improvement initiatives and always looks for opportunities to reduce product-cost. </p>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b>How You'll Create Impact</b></h2>
   </div>
   <p></p>
   <div>
    <br> 
    <ul>
     <li> Supervision of production teams to ensure targets for Quality – Costs - Delivery – People are achieved.</li>
     <li> Ensures manufacturing-volume requirements are met, On Time in Full, within budget and with the correct schedule mix.</li>
     <li> Effectively manages employee performance, including coaching, counseling, developing and monitoring employee’s and taking the appropriate performance management action where required.</li>
     <li> Facilitating open two-way communications regarding individual, team and company objectives and performance through weekly team meetings and daily interaction on the line.</li>
     <li> Develop Operational plans in conjunction with the Business Unit Leader to ensure alignment with overall Site and Operations functions strategy.</li>
     <li> Leads problem-solving initiatives and takes an active role in driving cross-functional collaboration with Manufacturing, Quality, Engineering, Maintenance &amp; Supply Chain groups with a view to reducing waste across the business.</li>
     <li> Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.</li>
     <li> Ensures compliance with all company H &amp; S policies and is responsible for all H &amp;S issues on the shift</li>
     <li> Develop a training program to achieve optimum cross training versatility and flexibility while maintaining all H &amp; S requirements.</li>
     <li> Administration duties which include updating metrics, Time and Attendance system, Holiday planning etc.</li>
    </ul>
    <p><b><i> This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.</i></b></p>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> What Makes You Stand Out</b></h2> 
   </div>
   <div>
    <ul>
     <li>Minimum of a level 7 in a Bachelor of Science / Engineering or relevant qualification.</li>
     <li> 3/4 years’ experience in a supervisory capacity in a manufacturing environment.</li>
     <li> Previous experience of people-management and demonstrated ability in people motivation, organising and team building would be a distinct advantage</li>
     <li> Metrics and Continuous improvement experience</li>
     <li> Excellent communication and influencing skills with proven ability to deliver results in a cross-function team-based environment</li>
     <li> Proven experience and knowledge of process improvements with the use of lean tools</li>
     <li> Proven ability of leadership within a change management environment. </li>
     <li>Good knowledge of GMP / FDA regulatory requirements, housekeeping, health and safety.</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> Your Background</b></h2> 
   </div>
  </div>
  <div></div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b>Travel Expectations</b></h2>
   </div>
  </div>
 </div>
 <div></div>
 <p><br> EOE/M/F/Vet/Disability</p>
</div>


 At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
 
  As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
 
  
   
     What You Can Expect 
   
   
     The Product Supervisor has overall responsibility for a Product Builder group in meeting its requirements in terms of Quality, Cost, Delivery, Supply, Safety and People. Strong communication, leadership and organizational skills are essential as well as a full understanding of the manufacturing process. Leads lean-manufacturing, productivity and quality- improvement initiatives and always looks for opportunities to reduce product-cost. 
   
  
  
   
    How You'll Create Impact
   
   
   
     
    
      Supervision of production teams to ensure targets for Quality – Costs - Delivery – People are achieved.
      Ensures manufacturing-volume requirements are met, On Time in Full, within budget and with the correct schedule mix.
      Effectively manages employee performance, including coaching, counseling, developing and monitoring employee’s and taking the appropriate performance management action where required.
      Facilitating open two-way communications regarding individual, team and company objectives and performance through weekly team meetings and daily interaction on the line.
      Develop Operational plans in conjunction with the Business Unit Leader to ensure alignment with overall Site and Operations functions strategy.
      Leads problem-solving initiatives and takes an active role in driving cross-functional collaboration with Manufacturing, Quality, Engineering, Maintenance & Supply Chain groups with a view to reducing waste across the business.
      Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
      Ensures compliance with all company H & S policies and is responsible for all H &S issues on the shift
      Develop a training program to achieve optimum cross training versatility and flexibility while maintaining all H & S requirements.
      Administration duties which include updating metrics, Time and Attendance system, Holiday planning etc.
    
     This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
   
  
  
   
     What Makes You Stand Out 
   
   
    
     Minimum of a level 7 in a Bachelor of Science / Engineering or relevant qualification.
      3/4 years’ experience in a supervisory capacity in a manufacturing environment.
      Previous experience of people-management and demonstrated ability in people motivation, organising and team building would be a distinct advantage
      Metrics and Continuous improvement experience
      Excellent communication and influencing skills with proven ability to deliver results in a cross-function team-based environment
      Proven experience and knowledge of process improvements with the use of lean tools
      Proven ability of leadership within a change management environment. 
     Good knowledge of GMP / FDA regulatory requirements, housekeeping, health and safety.
    
   
  
  
   
     Your Background 
   
  
  
  
   
    Travel Expectations
   
  
 
 
  EOE/M/F/Vet/Disability


Production Supervisor - Zimmer Biomet

Production Supervisor

You need a Bachelor's in IT or related field, 6 years in JDE ERP, 4 years in medical validation and manufacturing support, and 3 years in project management and troubleshooting. 20% travel required.

You will design supply chain solutions, manage IT projects, collaborate with business teams, validate SAP IBP solutions, conduct testing, and facilitate user training and support.

<div>
 <p>At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.</p>
 <p> As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.</p>
 <div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b><br> Duties</b></h2> 
   </div>
   <div>
    <ul>
     <li>Solution Designing &amp; Partnering with Business: Partner with Business team on any new Strategic Decision on Supply Chain initiative; Helping the Business team in Defining the business requirements which can be materialized by the IT solution; Validation of any solution in SAP IBP and getting approved from SAP vendor / COE teams; Conducting brainstorming workshops on key Supply Chain IT solution designs; Working with Various ERP teams like JDE, SAP ECC and Legacy Systems in defining their solution related to Supply chain functions also validate any of their local solutions to comply with Supply Chain strategy; Coordinating with COE, Central planning, Global operations, Supply Chain IT and Supporting IT teams on any solution initiatives.</li>
     <li>E2E Supply Chain Solution ownership: Creating the solution Design; Solution Blue print / Straw man solution creation; Work with IT teams to develop the solution; Defining &amp; reviewing Test Scenarios / Scripts as per the Business requirements; Review and manage testing &amp; Bug fixing; Creating &amp; Reviewing of user training documents; Defining the Cutover plan for solution deployment; Manage and Handle the Cutover and Deployment activities; Post Go live support of the solution.</li>
     <li>Technical evaluation and design: Develop and document IT processes, procedures, and standards; Ensure that project and system documentation is created as required including, but not limited to functional design specifications, technical design specifications, and relevant training documentation; Assist business partners with user acceptance testing co-ordinate with other system owners in system integration testing; Facilitate promotion of system changes by following approved change control processes; Defining solutions related to Supply chain metrics ensuring the business requirements are met; Conducting any RCA for business problems; Responsible for conducting periodic data analysis for the system Continuous improvement activities.</li>
     <li>Project management and Management of non-employee resources: Prepare status reports, project progress, and create solutions to IT problems/issues; Provide direction to peers, senior/junior team members and/or external consultants; Working closely with Business and IT PMO in any project initiatives to handle the end to end project execution starting from Project plan creation, monitor the project execution progress and project closure.</li>
    </ul>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> Requirements - Education &amp; Experience</b></h2> 
   </div>
   <div>
    <p> Education Requirement - Requires a Bachelor’s degree in Information Technology, Engineering, or related field, or foreign equivalent</p>
    <p> Must have 6 years of experience in ERP Implementations in JD Edwards (JDE) Systems.</p>
    <p> Must have 4 years of experience with:</p>
    <p> o Medical Industry Validation processes;</p>
    <p> o Supporting IT ERP systems for Medical Devices Manufacturing industry; and</p>
    <p> o Implementing &amp; Supporting manufacturing and Central Planning interface with JDE ERP system.</p>
    <p> Must have 3 years of experience with:</p>
    <p> o Troubleshooting, analyzing complex problems and challenges with ERP &amp; other Planning system, integration technologies;</p>
    <p> o Working MRP / CRP process in JDE ERP Modules;</p>
    <p> o Experience with ERP implementations;</p>
    <p> o JDE Sales Order Management, Purchase Order Management and Manufacturing modules;</p>
    <p> o Supporting and working with multiple regional teams from both Business and IT;</p>
    <p> o Project management skills associated with development and support of business applications, (identifying tasks, allocating resources, developing project timelines, managing project budget, communication of<br> project status);</p>
    <p> o Leading IT projects of medium to high complexity at the regional or global level; and</p>
    <p> o Global supply chain processes for the Make to stock environment.</p>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> Travel Expectations</b></h2> 
   </div>
   <div>
    <p> Requires 20% domestic and international travel.</p>
   </div>
  </div>
  <div>
   <div>
    <h2 class="jobSectionHeader"><b> Work Information</b></h2> 
   </div>
   <div>
    <p> Role requires work onsite in the Warsaw, IN, office 30% of time. Role permits remote work 70% of time</p>
   </div>
  </div>
 </div>
 <p><br> EOE/M/F/Vet/Disability</p>
</div>


 At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
  As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
 
  
   
     Duties 
   
   
    
     Solution Designing & Partnering with Business: Partner with Business team on any new Strategic Decision on Supply Chain initiative; Helping the Business team in Defining the business requirements which can be materialized by the IT solution; Validation of any solution in SAP IBP and getting approved from SAP vendor / COE teams; Conducting brainstorming workshops on key Supply Chain IT solution designs; Working with Various ERP teams like JDE, SAP ECC and Legacy Systems in defining their solution related to Supply chain functions also validate any of their local solutions to comply with Supply Chain strategy; Coordinating with COE, Central planning, Global operations, Supply Chain IT and Supporting IT teams on any solution initiatives.
     E2E Supply Chain Solution ownership: Creating the solution Design; Solution Blue print / Straw man solution creation; Work with IT teams to develop the solution; Defining & reviewing Test Scenarios / Scripts as per the Business requirements; Review and manage testing & Bug fixing; Creating & Reviewing of user training documents; Defining the Cutover plan for solution deployment; Manage and Handle the Cutover and Deployment activities; Post Go live support of the solution.
     Technical evaluation and design: Develop and document IT processes, procedures, and standards; Ensure that project and system documentation is created as required including, but not limited to functional design specifications, technical design specifications, and relevant training documentation; Assist business partners with user acceptance testing co-ordinate with other system owners in system integration testing; Facilitate promotion of system changes by following approved change control processes; Defining solutions related to Supply chain metrics ensuring the business requirements are met; Conducting any RCA for business problems; Responsible for conducting periodic data analysis for the system Continuous improvement activities.
     Project management and Management of non-employee resources: Prepare status reports, project progress, and create solutions to IT problems/issues; Provide direction to peers, senior/junior team members and/or external consultants; Working closely with Business and IT PMO in any project initiatives to handle the end to end project execution starting from Project plan creation, monitor the project execution progress and project closure.
    
   
  
  
   
     Requirements - Education & Experience 
   
   
     Education Requirement - Requires a Bachelor’s degree in Information Technology, Engineering, or related field, or foreign equivalent
     Must have 6 years of experience in ERP Implementations in JD Edwards (JDE) Systems.
     Must have 4 years of experience with:
     o Medical Industry Validation processes;
     o Supporting IT ERP systems for Medical Devices Manufacturing industry; and
     o Implementing & Supporting manufacturing and Central Planning interface with JDE ERP system.
     Must have 3 years of experience with:
     o Troubleshooting, analyzing complex problems and challenges with ERP & other Planning system, integration technologies;
     o Working MRP / CRP process in JDE ERP Modules;
     o Experience with ERP implementations;
     o JDE Sales Order Management, Purchase Order Management and Manufacturing modules;
     o Supporting and working with multiple regional teams from both Business and IT;
     o Project management skills associated with development and support of business applications, (identifying tasks, allocating resources, developing project timelines, managing project budget, communication of project status);
     o Leading IT projects of medium to high complexity at the regional or global level; and
     o Global supply chain processes for the Make to stock environment.
   
  
  
   
     Travel Expectations 
   
   
     Requires 20% domestic and international travel.
   
  
  
   
     Work Information 
   
   
     Role requires work onsite in the Warsaw, IN, office 30% of time. Role permits remote work 70% of time
   
  
 
  EOE/M/F/Vet/Disability


Zimmer Biomet

navigation.mission