Regulatory Affairs Senior Specialist, New Product Development

Danaher

Sunnyvale, CA, USA
Base: $92,500 - $127,500; bonus/equity: eligible f...
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510k submission preparation and review
Fda regulatory submission expertise
Cross-functional team leadership
** Danaher is seeking a Regulatory Affairs Senior Specialist for New Product Development within Cepheid, focusing on developing diagnostic solutions. The role requires expertise in regulatory submissions, specifically 510(k) processes, and offers a remote work arrangement, emphasizing a culture of growth and innovation. **

Job Summary

  • The Regulatory Affairs Senior Specialist serves as the RA lead on New Product Development core teams, ensuring on-time delivery of product launches.
  • This role involves preparing regulatory submissions including formal written technical reports and interacting cross-functionally to advise on business decisions.
  • Cepheid offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) eligibility.

Matching Summary

Match Score: 75

** Danaher is seeking a Regulatory Affairs Senior Specialist for New Product Development within Cepheid, focusing on developing diagnostic solutions. The role requires expertise in regulatory submissions, specifically 510(k) processes, and offers a remote work arrangement, emphasizing a culture of growth and innovation. **

Salary

Base: $92,500 - $127,500; Bonus/Equity: Eligible for bonus/incentive pay; Benefits: Comprehensive package including health insurance and 401(k)

Skills & Requirements

Must-have

  • 510k submission preparation and review
  • FDA regulatory submission expertise
  • Cross-functional team leadership

Nice-to-have

  • Experience with PMA submissions preferred
  • Ability to adapt in fast-paced environment
  • Continuous improvement methodology knowledge

Key Requirements

  • Bachelor's degree with 5+ years experience OR Master's with 3+ years
  • In-depth understanding of diagnostic product regulations
  • Required experience supporting 510k submissions

Work Rights

Not specified

Tailored Resume

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