Senior International Regulatory Affairs Specialist

BD

Franklin Lakes, NJ, USA
Base: $110,200.00 - $176,400.00 usd annual; bonus:...
Fully remote
6 years relevant work experience
Medical device regulatory frameworks
Latam and canada registration support
The role involves supporting the registration of medical devices in multiple countries within the LATAM region and Canada

Job Summary

  • The role involves supporting the registration of medical devices in multiple countries within the LATAM region and Canada.
  • Candidates must evaluate product design dossiers for consistency, congruency, and compliance with registration requirements.
  • BD offers a competitive compensation package including annual bonuses, comprehensive health benefits, and retirement plans.

Matching Summary

The role involves supporting the registration of medical devices in multiple countries within the LATAM region and Canada.

Salary

Base: $110,200.00 - $176,400.00 USD Annual; Bonus: Annual Bonus available; Benefits: Comprehensive health, dental, vision, 401(k), and wellness programs

Skills & Requirements

Must-have

  • 6 years relevant work experience
  • Medical device regulatory frameworks
  • LATAM and Canada registration support
  • Product design dossier evaluation
  • Cross-functional team collaboration

Nice-to-have

  • International regulatory affairs experience
  • ISO standards knowledge for medical devices
  • Master Control software proficiency
  • SAP proficiency at several levels
  • Experience with international organizations

Key Requirements

  • High School diploma with 6 years experience or Bachelor's degree preferred
  • Minimum 1 year international regulatory affairs experience preferred
  • Strong understanding of LATAM and Canada medical device regulations

Work Rights

Not specified

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