Sr. International Regulatory Affairs Specialist

Waters

Milpitas, California, United States
$106,600.00 - $175,900.00 usd annual; not specifie...
Fully remote
International regulatory affairs
Product registrations latam/apac
Notification of change (noc)
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

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.
  • BD is one of the largest global medical technology companies in the world, advancing the world of health™ and seeking individuals who can help reinvent the future of health.

Matching 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.

Salary

$106,600.00 - $175,900.00 USD Annual; Not specified; Not specified

Skills & Requirements

Must-have

  • International regulatory affairs
  • Product registrations LATAM/APAC
  • Notification of Change (NoC)
  • Regulatory intelligence
  • IVD and RUO products
  • Medical device regulatory requirements

Nice-to-have

  • Build effective relationships
  • Collaborate with cross-functional teams
  • Problem-solving skills
  • High attention to detail
  • Bilingual proficiency in Chinese/Mandarin

Key Requirements

  • Bachelor's degree or equivalent experience
  • 5–8 years of regulatory affairs experience
  • Experience supporting international regulatory submissions
  • Experience assessing regulatory impact of changes
  • Working knowledge of global IVD regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter