Sr. International Regulatory Affairs Specialist

BD

Milpitas, California, United States
Base: $106,600.00 - $175,900.00 usd annual; bonus/...
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International regulatory affairs
Product registration maintenance
Notification of change (noc) activities
** BD is seeking a Senior International Regulatory Affairs Specialist to manage and maintain product registrations in LATAM and APAC markets. The role requires extensive regulatory affairs experience, particularly in the medical device and IVD industries, alongside strong interpersonal and project management skills. **

Job Summary

  • The Senior Regulatory Affairs Specialist leads and independently executes international regulatory affairs activities with primary accountability for maintaining product registrations in LATAM and APAC markets.
  • This role ensures sustained market access through proactive management of registrations, assessment and coordination of regulatory change impacts, clear communication of country status and risks, and initiation or release of country specific ship/hold actions in collaboration with cross functional stakeholders.
  • The position provides regulatory guidance across the organization, supports audits and process improvement activities, and monitors evolving global regulatory requirements to assess business impact and inform regulatory and compliance strategies for IVD and RUO products.

Matching Summary

Match Score: 75

** BD is seeking a Senior International Regulatory Affairs Specialist to manage and maintain product registrations in LATAM and APAC markets. The role requires extensive regulatory affairs experience, particularly in the medical device and IVD industries, alongside strong interpersonal and project management skills. **

Salary

Base: $106,600.00 - $175,900.00 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • International regulatory affairs
  • Product registration maintenance
  • Notification of Change (NoC) activities
  • Regulatory intelligence
  • LATAM and APAC markets
  • IVD and RUO products

Nice-to-have

  • Bilingual proficiency in Chinese/Mandarin
  • RAC certification

Key Requirements

  • 5-8 years of regulatory affairs experience
  • Medical device and/or IVD industry experience
  • International regulatory submissions
  • Bachelor's degree in scientific, engineering, or medical discipline

Work Rights

Not specified

Tailored Resume

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