Regulatory Affairs Manager

BD

Covington, GA, US
Fully remote
Regulatory submissions and approvals
Compliance with medical device regulations
Regulatory strategy development
The Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices ensuring timely market access and maintaining post-market compliance

Job Summary

  • The Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices ensuring timely market access and maintaining post-market compliance.
  • BD prioritizes on-site collaboration to foster creativity, innovation, and effective problem-solving essential in the fast-paced healthcare industry.
  • A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work while helping each other learn and improve every day.

Matching Summary

The Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices ensuring timely market access and maintaining post-market compliance.

Skills & Requirements

Must-have

  • Regulatory submissions and approvals
  • Compliance with medical device regulations
  • Regulatory strategy development
  • Quality system regulations compliance
  • Cross-functional regulatory support
  • Regulatory license and registration management

Nice-to-have

  • Strong analytical and problem-solving abilities
  • Excellent communication skills
  • Ability to work independently and collaboratively
  • Regulatory training delivery
  • Proficiency in Microsoft Office Suite
  • Experience with regulatory submission software

Key Requirements

  • Bachelor's degree in scientific or engineering field
  • 5-7 years Regulatory Affairs experience in medical devices
  • Ability to work on-site in Covington, GA
  • Demonstrated success with FDA 510(k), PMA, CE Mark
  • In-depth knowledge of global medical device regulations
  • Strong understanding of ISO 13485 and 21 CFR Part 820
  • RAC certification preferred

Work Rights

Ability to work on-site in Covington, GA

Tailored Resume

Cover Letter