Base: $122,000 to $217,728 depending on location; ...
Fully remote
8+ years fda regulated medical device experience
Expertise in 510(k) and eu mdr compliance
Knowledge of iec 60601 and iso 14971 standards
The Principal Regulatory Affairs Specialist serves as a critical leadership role ensuring Philips medical device products are safe, effective, and compliant with global regulatory requirements
Job Summary
The Principal Regulatory Affairs Specialist serves as a critical leadership role ensuring Philips medical device products are safe, effective, and compliant with global regulatory requirements.
This position requires leading global regulatory strategies to support market expansion while embedding regulatory requirements into hardware system architecture and design activities.
Employees are eligible for a comprehensive benefits program including generous PTO, 401k match up to 7%, HSA contributions, and stock purchase plans.
Matching Summary
The Principal Regulatory Affairs Specialist serves as a critical leadership role ensuring Philips medical device products are safe, effective, and compliant with global regulatory requirements.
Salary
Base: $122,000 to $217,728 depending on location; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Generous PTO, 401k match, HSA, stock purchase plan, education reimbursement
Skills & Requirements
Must-have
8+ years FDA regulated medical device experience
Expertise in 510(k) and EU MDR compliance
Knowledge of IEC 60601 and ISO 14971 standards
Experience with system-level risk management
Hardware/software interface assessment skills
Nice-to-have
Familiarity with SaMD (IEC 82304)
Experience with international market expansion
Strong stakeholder relationship building
Mentoring technical leadership capabilities
Clear communication of complex topics
Key Requirements
Minimum 8+ years Regulatory Affairs experience
Bachelor's Degree in Scientific or Technical discipline
US work authorization required without sponsorship
Residency in Colorado Springs, Cambridge, San Diego, or Plymouth