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Regulatory Affairs Associate - Hybrid

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BD

23d ago

  • Job
    Full-time
    Entry Level
  • Tempe

AI generated summary

  • You need a relevant degree, experience in medical devices and regulatory affairs, strong analytical and communication skills, and the ability to work independently with minimal supervision.
  • You will ensure product changes meet regulatory compliance, support global notifications, assist in submission preparations, review promotional materials, and maintain regulatory databases.

Requirements

  • Ability to plan and schedule multiple priorities in a concurrent fashion.
  • Ability to review, collate and summarize scientific and technical data.
  • Ability to learn new technical concepts.
  • Problem solving and analytical skills.
  • Strong written and oral communication skills.
  • Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends.
  • Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field, or equivalent combination of related education and experience.
  • Previous experience in the medical device industry.
  • Previous regulatory affairs experience, e.g., RA Internship.
  • Methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
  • Ability to complete assigned work with minimal supervision and ability to work independently.

Responsibilities

  • Reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications.
  • Communicates changes to global regions and supports preparation of global notifications as needed.
  • Participates in core teams and provides guidance on regulatory requirements to product development teams, with guidance/support from management.
  • Assists in the preparation of dossiers and submission packages for regulatory agencies.
  • Supports strategic regulatory activities of a more senior RA team member.
  • Reviews advertising and promotional material product line(s) and/or regions(s) as needed.
  • Maintains regulatory databases/systems with key regulatory data as needed.
  • May participate in regulatory body audits in a supporting role.

FAQs

What is the role of a Regulatory Affairs Associate?

The Regulatory Affairs Associate is an entry-level role responsible for providing regulatory support for product lines and regions, participating in new product development teams, and preparing regulatory submissions for medical devices in global markets.

What are the primary responsibilities of this position?

The primary responsibilities include reviewing product changes for regulatory compliance, communicating changes to global regions, participating in core teams, assisting in the preparation of regulatory submissions, and maintaining regulatory databases.

What qualifications are required for this job?

Required qualifications include the ability to plan multiple priorities, review and summarize scientific data, solve problems analytically, and possess strong communication skills. A bachelor's or advanced degree in a technical field is also required.

Are there preferred qualifications for this role?

Yes, preferred qualifications include previous experience in the medical device industry, regulatory affairs experience (such as an internship), attention to detail, and the ability to work independently with minimal supervision.

What is the expected work schedule for this position?

The position requires a minimum of 4 days of in-office presence per week due to the company’s emphasis on collaboration and innovation.

Is COVID-19 vaccination required for this position?

Yes, for certain roles at BD, employment is contingent on providing proof of full vaccination against COVID-19, and some locations may offer testing or accommodations as per applicable laws.

Where is this position located?

The primary work location is at the USA AZ - Tempe Headquarters.

Is there room for growth in this career at BD?

Yes, BD provides a supportive environment focused on learning, growth, and career development, encouraging employees to bring their authentic selves to work.

What type of company culture does BD promote?

BD promotes a culture of collaboration, accountability, and continuous improvement, valuing contributions and helping each other achieve excellence.

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BD

BD is a global medical technology company that is advancing the world of health™. www.bd.com

Manufacturing & Electronics
Industry
10,001+
Employees

Mission & Purpose

BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.