Regulatory Affairs Senior Specialist, New Product Development

Cepheid

Sunnyvale, CA, USA
Base: $92,500 - $127,500; bonus/equity: eligible f...
Remote
Regulatory submission preparation
Cross-functional team leadership
Interaction with regulatory authorities
Cepheid is seeking a Regulatory Affairs Senior Specialist for New Product Development, who will lead regulatory submissions and collaborate with cross-functional teams to ensure successful product launches. The position is remote, offers competitive benefits, and emphasizes career growth within the biotechnology field

Job Summary

  • The Regulatory Affairs Senior Specialist serves as the RA lead on New Product Development (NPD) core teams working on simple to medium complicated assay, instrument, software projects and/or system projects.
  • This individual prepares the regulatory submissions and interacts cross-functionally to ensure on-time delivery (OTD) of product launches.
  • This role offers exposure to diverse products and projects, DBS tools to implement continuous improvement, and drives introduction of new product availability while enhancing career growth within Regulatory Affairs.

Matching Summary

Match Score: 85

Cepheid is seeking a Regulatory Affairs Senior Specialist for New Product Development, who will lead regulatory submissions and collaborate with cross-functional teams to ensure successful product launches. The position is remote, offers competitive benefits, and emphasizes career growth within the biotechnology field.

Salary

Base: $92,500 - $127,500; Bonus/Equity: Eligible for bonus/incentive pay; Benefits: Comprehensive package including paid time off, medical/dental/vision insurance and 401(k)

Skills & Requirements

Must-have

  • Regulatory submission preparation
  • Cross-functional team leadership
  • Interaction with regulatory authorities
  • New product development support
  • Diagnostic product regulations

Nice-to-have

  • Continuous improvement implementation
  • Career growth opportunities
  • Adaptable in dynamic environment
  • Keeping abreast of regulatory changes

Key Requirements

  • Bachelor's degree with 5+ years experience OR Master's degree with 3+ years experience OR Doctoral degree with 0-2 years experience
  • Familiarity with diagnostic product regulations
  • Experience supporting 510k submissions
  • Ability to prioritize and multitask
  • Detail-oriented with analytical skills

Work Rights

Not specified

Tailored Resume

Cover Letter