Regulatory Affairs Specialist

4 weeks ago

Tempe, Arizona, United States BD (Becton, Dickinson and Company) Full time

Job Description Summary

As a Regulatory Affairs Specialist at BD, you will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product.

The RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets.

The RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns.

Candidates must be able to work in our Tempe, AZ office 3 days a week.

Primary Job Responsibilities:

  1. Understands fundamental global regulatory requirements and different regulatory pathways.
  2. Understands scientific and health principles related to healthcare product development and regulations.
  3. Participates in core teams as regulatory lead and provides guidance on regulatory requirements to product development teams, with some support from management.
  4. Assists and/or has ownership in preparation of dossiers and submission packages for regulatory agencies.
  5. Supports development of regulatory strategies for marketing authorization for global markets.
  6. Independently reviews product changes to ensure regulatory compliance. Communicates changes to global regions and supports preparation of global notifications as needed.
  7. Assists in the preparation and sending of post-market reports and submissions.
  8. Participates in training of colleagues, as needed, for areas of expertise.
  9. Maintains regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s).
  10. May participate in regulatory body audits, as related to respective product line(s) and/or region(s).

About You:

Minimum bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of one year of experience, or equivalent combination of related education and experience.

Minimum of two years of regulatory or quality experience in the medical device industry.

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 and skills.

Excellent problem solving and analytical skills.

Excellent written and oral communication skills.

Preferred Qualifications:

  1. Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
  2. Ability to complete work with minimal supervision and ability to work independently.
  3. Previous experience in regulatory body audit support.
  4. Experience with regulatory tools and systems.
  5. Excellent writing and strong organizational skills.
  6. International regulatory experience.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.

It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.

We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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