Principal Regulatory Affairs Specialist

Philips

Murrysville, PA, USA
Base: $114,750 to $183,600; bonus/equity: not spec...
Fully remote
7+ years in regulatory affairs
Expertise in software as a medical device
Experience with 510k submissions
The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development

Job Summary

  • The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development.
  • You will act as a Regulatory Subject Matter Expert and provide strategic guidance to project teams.
  • Philips offers a comprehensive benefits program including generous PTO and 401k matching.

Matching Summary

The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development.

Salary

Base: $114,750 to $183,600; Bonus/Equity: Not specified; Benefits: Comprehensive Philips Total Rewards program

Skills & Requirements

Must-have

  • 7+ years in Regulatory Affairs
  • Expertise in Software as a Medical Device
  • Experience with 510K submissions

Nice-to-have

  • Strong relationship-building skills
  • Ability to guide cross-functional teams

Key Requirements

  • Bachelor's Degree required
  • RAPS certification preferred
  • Knowledge of FDA and EU MDR regulations

Work Rights

Not specified

Tailored Resume

Cover Letter