Sr. International Regulatory Affairs Specialist

BD

Milpitas, CA, USA
Base: $106,600.00 - $175,900.00 usd annual; bonus/...
Fully remote
5-8 years medical device regulatory experience
Latam and apac market registration expertise
Notification of change (noc) coordination
The role leads international regulatory activities for IVD products specifically focusing on LATAM and APAC markets outside the US and EU

Job Summary

  • The role leads international regulatory activities for IVD products specifically focusing on LATAM and APAC markets outside the US and EU.
  • Candidates must own Notification of Change activities, manage country licenses, and initiate ship/hold decisions to ensure sustained market access.
  • BD offers a culture that values authentic self-expression, continuous learning, and collaborative innovation across global teams.

Matching Summary

The role leads international regulatory activities for IVD products specifically focusing on LATAM and APAC markets outside the US and EU.

Salary

Base: $106,600.00 - $175,900.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including well-being and development rewards

Skills & Requirements

Must-have

  • 5-8 years medical device regulatory experience
  • LATAM and APAC market registration expertise
  • Notification of Change (NoC) coordination
  • IVD regulatory requirements knowledge
  • Cross-functional stakeholder collaboration

Nice-to-have

  • Bilingual proficiency in Chinese/Mandarin
  • RAC certification preferred
  • Master's degree in life sciences
  • Experience with Waters Corporation integration
  • Strong project management in matrixed environment

Key Requirements

  • Bachelor's degree in scientific or engineering discipline
  • Minimum 5-8 years regulatory affairs experience
  • Experience with ISO 13485 and global IVD standards
  • Ability to work independently with limited supervision
  • Proficiency in managing multiple priorities in regulated environments

Work Rights

Not specified

Tailored Resume

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