Principal Regulatory Affairs Specialist

Philips UK

Colorado Springs, CO, US
Colorado springs, co: $122,000 to $194,400; san di...
Fully remote
Us fda 510(k) compliance
Eu mdr technical documentation
Global regulatory strategies
Play a critical leadership role as a Senior regulatory subject-matter expert, ensuring Philips medical device products are safe, effective, and compliant with applicable global regulatory requirements

Job Summary

  • Play a critical leadership role as a Senior regulatory subject-matter expert, ensuring Philips medical device products are safe, effective, and compliant with applicable global regulatory requirements.
  • Lead and influence global regulatory strategies to support market expansion and lifecycle management, with emphasis on system-level hardware integration considerations for US, EU, Japan, Canada, and other international markets as required.
  • We believe that we are better together than a part. For our office-based teams, this means working in-person at least 3 days per week.

Matching Summary

Play a critical leadership role as a Senior regulatory subject-matter expert, ensuring Philips medical device products are safe, effective, and compliant with applicable global regulatory requirements.

Salary

Colorado Springs, CO: $122,000 to $194,400; San Diego, CA and Cambridge, MA: $137,000 to $217,728; Plymouth, MN: $128,000 to $204,120; Bonus/Equity: Annual incentive bonus, sales commission or long-term incentives may be offered; Benefits: Comprehensive Philips Total Rewards benefits program including PTO, 401k, HSA, stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • US FDA 510(k) compliance
  • EU MDR Technical Documentation
  • Global regulatory strategies
  • Hardware system integration
  • Risk management and hazard analysis
  • Notified Body interactions

Nice-to-have

  • Mentoring regulatory professionals
  • Communicating complex topics
  • Building strong stakeholder relationships

Key Requirements

  • 8+ years Regulatory Affairs experience
  • FDA regulated Medical Device experience
  • Bachelors’ Degree in Scientific or Technical discipline
  • US work authorization required

Work Rights

US work authorization is a precondition of employment

Tailored Resume

Cover Letter