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Device Development Assurance Scientist

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Viatris

17d ago

  • Job
    Full-time
    Junior & Mid Level
  • Science
    Engineering
  • Dublin
  • Quick Apply

AI generated summary

  • You need a Bachelor's in Engineering/Biotech, 2-3 years in GMP/Medical Device, strong problem-solving skills, and knowledge of GMP, ISO, CFR, and core manufacturing principles.
  • You will support post-market activities, collaborate cross-functionally, manage product lifecycle, ensure compliance, conduct audits, and oversee CAPA processes for combination products and medical devices.

Requirements

  • Bachelor’s degree in Engineering or Biotechnology
  • Minimum 2-3 years relevant professional experience (GMP / Medical Device /Risk Management/Post Market)
  • Demonstrated ability to perform in a high-performing workforce
  • Demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745
  • Strong problem solving and analytical skills
  • Possess knowledge of core manufacturing / laboratory operation principles

Responsibilities

  • - Supporting post market activities for the Viatris combination products and medical device portfolio, within the Global Device Development group.
  • - Promoting Cross-Functional collaboration and capable of working independently on projects with stakeholders both internal and external to the Global Device Development group.
  • - Supporting the life-cycle management (LCM) activities for Vaitris combination product and medical device programs that are:
  • - In the post-production phase
  • - Transitioning from development phase into the post-production phase
  • - Acquired by Vaitris and require integration into the GDD QMS
  • - DHF documentation gap analysis, review and updates to GxP requirements.
  • - Ensuring compliance to EU MDR/FDA regulations by maintaining awareness, and application of: ongoing industry best practices, relevant regulation/standard changes, GxP requirements.
  • - Participation in various design quality assurance and compliance improvement, continuous improvement projects in conjunction with the QMS team, cross functional development teams, and Global sites (when required).
  • - Supporting internal cross functional development team group, and Global external teams, through product life cycle process; with respect to design control, and risk management deliverables for post production programs.
  • - Supporting the CAPA process, including identifying root causes, developing and implementing corrective actions, verifying the effectiveness of actions taken, and ensuring timely closure of CAPAs in compliance with quality management systems and regulatory requirements.
  • - Supporting the execution of Internal Audits, third-party inspections/audits, and corporate Quality audits.

FAQs

What is the primary focus of the Device Development Assurance Scientist role?

The primary focus of the Device Development Assurance Scientist role is to support the life-cycle management activities for Viatris combination products and medical device programs, particularly in post-production and transition phases.

What qualifications are required for the Device Development Assurance Scientist position?

Candidates should have a Bachelor’s degree in Engineering or Biotechnology, with a minimum of 2-3 years of relevant professional experience in GMP, Medical Devices, Risk Management, or Post Market activities.

What regulatory knowledge is essential for this role?

A demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745 is essential for the position.

How important is cross-functional collaboration in this role?

Cross-functional collaboration is highly valued as the role involves working independently on projects with both internal and external stakeholders across various teams.

What type of projects will the Device Development Assurance Scientist be involved in?

The scientist will participate in design quality assurance, compliance improvement projects, and support the CAPA process, among other lifecycle management activities.

Are there opportunities for career advancement within Viatris?

Yes, Viatris offers excellent career progression opportunities for its employees.

What benefits are available to employees at Viatris?

Benefits include competitive salaries, work-life balance initiatives, a bonus scheme, health insurance, and a pension plan.

Does Viatris promote diversity and inclusion in the workplace?

Yes, Viatris is dedicated to building a diverse, inclusive, and authentic workplace, viewing diversity as a key strength in achieving its mission.

How does Viatris approach corporate social responsibility?

Viatris values corporate social responsibility and strives to advance responsible and sustainable operations that positively impact the communities and stakeholders it serves.

What is the work environment like at Viatris?

The work environment at Viatris is collaborative and designed to foster courage, resilience, and a culture where employees can realize their full potential.

Viatris

We believe in healthcare not as it is, but as it should be

Manufacturing & Electronics
Industry
10,001+
Employees
2020
Founded Year

Mission & Purpose

Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. Our differentiated portfolio includes brands, generics, and complex generics across multiple therapeutic areas. Our product diversity combined with our global scale, local approach and deep understanding of our markets allows for better access to customers and patients in more than 165 countries and territories. From our unique vantage point, we have the ability to touch all of life’s moments from acute conditions to chronic diseases. We put the person at the center of their own unique health journey. Viatris is more than a place to work, it is a place to make an impact in the world. Our culture is performance-driven, highly engaging and inclusive. We support and invest in our colleagues living, learning, growing and achieving on behalf of our mission. Four simple but powerful expectations define The Viatris Way – Own It. Be Real. Stay Agile. Take Pride. Ultimately, we know we are Stronger Together, working collaboratively and relentlessly across our company and with the broader global community, in pursuit of access. Because health matters everywhere.

Benefits

  • Retirement savings plans

  • Paid time off and holidays

  • Remote and flexible work arrangements in most locations