Regulatory Affairs Specialist Ii

BD

Covington, GA, USA
Fully remote
Bs in scientific field or regulated industry
2+ years regulatory experience
1 year medical devices experience
The role involves preparing U.S. and CE marking submissions while supporting regulatory strategy across the product lifecycle

Job Summary

  • The role involves preparing U.S. and CE marking submissions while supporting regulatory strategy across the product lifecycle.
  • Candidates must be able to update STED technical files for EU/MDR product maintenance and interact with notified bodies.
  • The position offers a hybrid work model requiring on-site presence four days a week in Covington with remote Fridays.

Matching Summary

The role involves preparing U.S. and CE marking submissions while supporting regulatory strategy across the product lifecycle.

Skills & Requirements

Must-have

  • BS in Scientific Field or Regulated Industry
  • 2+ years Regulatory experience
  • 1 year medical devices experience
  • Knowledge of US and European regulations
  • Technical writing skills for submissions

Nice-to-have

  • RAC Certification preferred
  • Experience with 510(k) submissions
  • Ability to work independently
  • Cross-functional collaboration skills
  • Self-motivated ownership style

Key Requirements

  • Bachelor's degree required
  • 2+ years regulatory experience
  • 1 year medical device experience
  • RAC certification preferred
  • US and EU regulation knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter