Regulatory Affairs Specialist

Becton, Dickinson and Company

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 accurate regulatory documentation
Becton, Dickinson and Company is seeking a Regulatory Affairs Specialist to support the preparation and submission of regulatory documents for medical devices. The position requires compliance with global regulations and collaboration with cross-functional teams, and offers a fully remote work option

Job Summary

  • The Regulatory Affairs Specialist is responsible for supporting the preparation and submission of regulatory documents to health authorities, ensuring compliance with global regulations for medical devices.
  • At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.
  • BD offers a competitive compensation package along with comprehensive benefits including medical coverage, retirement plans, and various well-being resources.

Matching Summary

Match Score: 85

Becton, Dickinson and Company is seeking a Regulatory Affairs Specialist to support the preparation and submission of regulatory documents for medical devices. The position requires compliance with global regulations and collaboration with cross-functional teams, and offers a fully remote work option.

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 accurate regulatory documentation
  • Collaborate with cross-functional teams

Nice-to-have

  • Strong analytical and problem-solving skills
  • Ability to work independently in fast-paced environment
  • Excellent written and verbal communication skills

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

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