Principal Regulatory Affairs Specialist

Philips • San Diego, CA

6d • Onsite

About The Position

The Principal Regulatory Affairs Specialist plays 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, with a primary focus on US/FDA 510(k), EU MDR, and complex hardware-based medical systems, including international market expansion (e.g., Japan and Canada). Your role: Serve as a Principal Regulatory expert for 510(k) and EU MDR compliance, including interpretation and application of regulations, guidance, and standards across integrated hardware systems and complex device portfolios. 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. Provide regulatory leadership and strategic guidance to internal stakeholders (R&D, Quality, Clinical, Marketing, Manufacturing, Supply Chain, etc.) to ensure regulatory requirements are embedded into hardware system architecture, design inputs, verification, and validation activities. Drive preparation, review, and maintenance of EU MDR Technical Documentation, including oversight of conformity assessment activities and interactions with Notified Bodies. Partner closely with hardware and systems engineering teams to support regulatory assessments of: System-level risk management and hazard analysis Hardware/software interfaces Design changes and impact assessments Verification and validation strategies for integrated systems Support and/or lead international regulatory submissions, registrations, and renewals, including coordination of submission strategies, gap assessments, and risk mitigation plans. Act as a key regulatory interface during Notified Body audits, regulatory inspections, and QMS audits, including preparation, participation, and follow-up activities. Provide regulatory input for post-market surveillance, vigilance, and change management, ensuring ongoing compliance throughout the product lifecycle. Mentor and provide technical leadership to other Regulatory Affairs professionals, supporting capability development and consistent regulatory execution. Communicate complex regulatory topics clearly and effectively to senior leadership and cross-functional teams, enabling informed decision-making on hardware design tradeoffs and system integration risks.

Requirements

• You've acquired a minimum of 8+ years' experience in Regulatory Affairs within FDA regulated Medical Device environments including 510(k)s, PMA supplements, EU MDR Technical Documents, and pre-submissions.
• You have proven expertise/knowledge in Regulations/Standards for hardware (IEC 60601), Software (IEC 62304), Risk Management (ISO 14971) and experience with SaMD (IEC 82304) is preferred.
• You have familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international regulatory standards, regulations, and submission paths.
• You have a minimum of a Bachelors’ Degree (Required) in a Scientific or Technical discipline (Engineering, Biology, Biomedical Engineering, Pharmacy, Chemistry, or similar)
• You have the proven ability to build strong relationships with internal and external stakeholders at all levels, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Responsibilities

• Serve as a Principal Regulatory expert for 510(k) and EU MDR compliance
• Lead and influence global regulatory strategies to support market expansion and lifecycle management
• Provide regulatory leadership and strategic guidance to internal stakeholders
• Drive preparation, review, and maintenance of EU MDR Technical Documentation
• Partner closely with hardware and systems engineering teams to support regulatory assessments
• Support and/or lead international regulatory submissions, registrations, and renewals
• Act as a key regulatory interface during Notified Body audits, regulatory inspections, and QMS audits
• Provide regulatory input for post-market surveillance, vigilance, and change management
• Mentor and provide technical leadership to other Regulatory Affairs professionals
• Communicate complex regulatory topics clearly and effectively to senior leadership and cross-functional teams

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level