Principal Regulatory Affairs Specialist

Philips

Murrysville, PA, USA
Base: $122,000 to $217,000; bonus/equity: not spec...
Fully remote
Regulatory oversight for product development
Experience with fda regulated environments
Strong knowledge of ce marking and fda compliance
The Principal Regulatory Affairs Specialist will lead regulatory oversight for new product development projects

Job Summary

  • The Principal Regulatory Affairs Specialist will lead regulatory oversight for new product development projects.
  • You will mentor and coach regulatory professionals while negotiating with regulatory enforcement entities.
  • Philips is committed to improving lives through health technology and offers a comprehensive benefits program.

Matching Summary

The Principal Regulatory Affairs Specialist will lead regulatory oversight for new product development projects.

Salary

Base: $122,000 to $217,000; Bonus/Equity: Not specified; Benefits: Comprehensive benefits program including PTO and 401k

Skills & Requirements

Must-have

  • Regulatory oversight for product development
  • Experience with FDA regulated environments
  • Strong knowledge of CE Marking and FDA compliance

Nice-to-have

  • Mentoring and coaching regulatory professionals
  • Negotiating with regulatory entities
  • Driving improvement in quality management systems

Key Requirements

  • Minimum of 8 years in Regulatory Affairs
  • Bachelor's Degree in relevant field
  • Experience with Software as Medical Device and Ultrasound Imaging Devices

Work Rights

Not specified

Tailored Resume

Cover Letter