Senior Regulatory Affairs Specialist

Philips

Bedford, MA, US
Base: $105,000 to $168,000; bonus/equity: annual i...
Fully remote
5+ years fda regulated medical device experience
Expertise in 510(k) and eu mdr submissions
System-level risk management and hazard analysis
The Senior Regulatory Affairs Specialist ensures Philips Image Guided Therapy products are safe, effective, and compliant with global regulatory requirements

Job Summary

  • The Senior Regulatory Affairs Specialist ensures Philips Image Guided Therapy products are safe, effective, and compliant with global regulatory requirements.
  • This role involves leading global regulatory strategies to support market expansion while managing system-level hardware integration considerations across multiple international markets.
  • Employees are eligible for a comprehensive benefits program including generous PTO, a 401k match up to 7%, and stock purchase plans.

Matching Summary

The Senior Regulatory Affairs Specialist ensures Philips Image Guided Therapy products are safe, effective, and compliant with global regulatory requirements.

Salary

Base: $105,000 to $168,000; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Generous PTO, 401k match, HSA contribution, stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • 5+ years FDA regulated medical device experience
  • Expertise in 510(k) and EU MDR submissions
  • System-level risk management and hazard analysis
  • Hardware/software interface regulatory assessments
  • Notified Body audit preparation and participation

Nice-to-have

  • Mentoring regulatory affairs professionals
  • Strategic guidance for global market expansion
  • Cross-functional stakeholder relationship building
  • Experience with complex integrated hardware systems

Key Requirements

  • Minimum 5 years experience in FDA regulated Medical Device environments
  • Bachelor's degree required; Master's degree desired
  • RAC certification preferred
  • US work authorization required without sponsorship

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter