Regulatory Affairs Specialist

BD

Franklin Lakes, NJ, USA
Base: $84,300.00 - $138,900.00 usd annual; bonus/e...
Fully remote
Prepare and submit regulatory filings
Review product changes for regulatory impact
Maintain regulatory documentation databases
BD is seeking a Regulatory Affairs Specialist to support the preparation and submission of regulatory documents for medical devices, ensuring compliance with global standards. The position requires a scientific background and experience in the medical device industry, while offering a competitive benefits package

Job Summary

  • The Regulatory Affairs Specialist is responsible for supporting the preparation and submission of regulatory documents to health authorities while ensuring compliance with global regulations.
  • BD offers a competitive compensation package along with comprehensive benefits including medical coverage, retirement plans, and extensive well-being resources.
  • The role requires a minimum of 4 days of in-office presence per week to foster creativity, innovation, and effective problem-solving within the team.

Matching Summary

Match Score: 85

BD is seeking a Regulatory Affairs Specialist to support the preparation and submission of regulatory documents for medical devices, ensuring compliance with global standards. The position requires a scientific background and experience in the medical device industry, while offering a competitive benefits package.

Salary

Base: $84,300.00 - $138,900.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive health, dental, vision, 401(k), wellness programs

Skills & Requirements

Must-have

  • Prepare and submit regulatory filings
  • Review product changes for regulatory impact
  • Maintain regulatory documentation databases
  • Collaborate with cross-functional teams
  • Monitor global medical device regulations

Nice-to-have

  • Strong analytical and problem-solving skills
  • Ability to work independently in fast-paced environment
  • Excellent written and verbal communication
  • Proficiency in Microsoft Office Suite
  • Commitment to on-site collaboration

Key Requirements

  • Bachelor's degree in scientific discipline
  • 1+ years experience in medical device industry
  • Understanding of FDA 21 CFR Part 820 and EU MDR/IVDR
  • Experience preparing 510(k)s and CE Mark Technical Files
  • RAC certification is a plus

Work Rights

Not specified

Tailored Resume

Cover Letter