Senior Regulatory Affairs Specialist, Operations

3 weeks ago


Covington, Georgia, United States BD (Becton, Dickinson and Company) Full time
Job Title: Senior Regulatory Affairs Specialist, Operations

BD (Becton, Dickinson and Company) is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for preparing U.S and CE marking submissions/registration activities, with a primary focus on EU/MDR, as well as supporting all other geographical regions registrations.

Key Responsibilities:

  • Preparation of U.S and CE marking submissions/registration activities
  • Supporting all other geographical regions registrations
  • Regulatory support through the product life cycle on product project teams
  • Developing regulatory strategies, change control assessments, timeline development, and reviewing submission related documents
  • Maintaining EU/MDR product registrations

Requirements:

  • Regulatory Affairs Certification (RAC) preferred
  • Minimum of 4 years' experience in Regulatory (to include some experience within medical device); experience in areas of product registration, compliance or quality systems highly preferred
  • Familiarity with STED and/or technical file updates for CE marking activities and notified body interaction to maintain EU/MDR product registrations
  • Ability to maintain confidentiality in dealing with regulatory and clinical documentation
  • Ability to prioritize and handle several projects concurrently

About BD:

BD (Becton, Dickinson and Company) is one of the largest global medical technology companies in the world. We are committed to advancing the world of health by improving medical discovery, diagnostics, and patient care. Our purpose is to help people live healthy lives and to improve the world at large.

What We Offer:

  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A comprehensive benefits package
  • A commitment to diversity, equity, and inclusion

How to Apply:

If you are a motivated and experienced regulatory affairs professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].



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