Sr. International Regulatory Affairs Specialist

Waters Corporation

Milpitas, CA, USA
Base: $106,600.00 - $175,900.00 usd annual; bonus/...
Fully remote
5-8 years regulatory affairs experience
Ivd device registration in latam and apac
Notification of change management
Waters Corporation is seeking a Senior International Regulatory Affairs Specialist to manage regulatory activities for product registrations in LATAM and APAC markets. The role focuses on ensuring market access, providing regulatory guidance, and monitoring global regulatory changes primarily for IVD and RUO products

Job Summary

  • The role leads international regulatory activities for IVD products, specifically managing registrations in LATAM and APAC markets.
  • Candidates must possess a proven track record of managing Notification of Change activities and assessing regulatory impacts on business operations.
  • Waters Corporation offers a culture of relentless innovation where associates are supported to learn, grow, and become their best self.

Matching Summary

Match Score: 85

Waters Corporation is seeking a Senior International Regulatory Affairs Specialist to manage regulatory activities for product registrations in LATAM and APAC markets. The role focuses on ensuring market access, providing regulatory guidance, and monitoring global regulatory changes primarily for IVD and RUO products.

Salary

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

Skills & Requirements

Must-have

  • 5-8 years regulatory affairs experience
  • IVD device registration in LATAM and APAC
  • Notification of Change management
  • Global regulatory intelligence monitoring
  • Cross-functional stakeholder collaboration

Nice-to-have

  • Bilingual proficiency in Chinese or 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 medical device/IVD regulatory experience
  • Working knowledge of ISO 13485 and global IVD standards

Work Rights

Not specified

Tailored Resume

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