Principal Regulatory Affairs Specialist

Philips

Murrysville, PA, United States
Base: $122,000 to $217,000 depending on location; ...
Fully remote
8+ years regulatory affairs experience
Fda regulated medical device environment
Global regulatory compliance knowledge
This role leads critical new product development projects ensuring Ultrasound products meet FDA and global regulatory standards

Job Summary

  • This role leads critical new product development projects ensuring Ultrasound products meet FDA and global regulatory standards.
  • The successful candidate will negotiate directly with regulatory enforcement entities on filings and represent the organization in internal and external audits.
  • Employees are eligible for a comprehensive benefits program including generous PTO, 401k match up to 7%, and stock purchase plans.

Matching Summary

This role leads critical new product development projects ensuring Ultrasound products meet FDA and global regulatory standards.

Salary

Base: $122,000 to $217,000 depending on location; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Generous PTO, 401k match, HSA contribution, stock purchase plan

Skills & Requirements

Must-have

  • 8+ years Regulatory Affairs experience
  • FDA regulated Medical Device environment
  • Global regulatory compliance knowledge
  • Technical Documentation submission expertise
  • Clinical study protocol review

Nice-to-have

  • Software as Medical Device (SaMD) experience
  • Ultrasound Imaging Devices background
  • RAC Certification preferred
  • Master's degree in relevant field
  • International committee representation

Key Requirements

  • Minimum 8 years RA experience
  • Bachelor's degree required
  • US work authorization required
  • No visa sponsorship available
  • Experience with 510(k), De Novo, PMA submissions

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter