Regulatory Affairs Senior Specialist, New Product Development

Cepheid

Remote
Base: $92,500 - $127,500; bonus/equity: eligible f...
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Regulatory submissions
New product development (npd)
Cross-functional interaction
** Cepheid is seeking a Regulatory Affairs Senior Specialist in New Product Development for a remote position. The role focuses on preparing regulatory submissions and providing leadership on cross-functional teams to ensure timely product launches. **

Job Summary

  • Serve as the RA lead on New Product Development (NPD) core teams working on assay, instrument, software projects and/or system projects.
  • Prepare regulatory submissions and interact cross-functionally to ensure on-time delivery 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: 75

** Cepheid is seeking a Regulatory Affairs Senior Specialist in New Product Development for a remote position. The role focuses on preparing regulatory submissions and providing leadership on cross-functional teams to ensure timely product launches. **

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 submissions
  • New Product Development (NPD)
  • Cross-functional interaction
  • Regulatory authorities interaction
  • Diagnostic product regulations

Nice-to-have

  • Continuous improvement
  • Career growth and development
  • Fast-paced environment
  • Flexible and adaptable

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 regulations/guidelines governing diagnostic products
  • Experience supporting 510k submissions
  • Ability to prioritize, multi-task, and organize work
  • Detail oriented with good analytical skills

Work Rights

Not specified

Tailored Resume

Cover Letter