Senior Regulatory Affairs Specialist

Philips • Orange, CA

12d • Onsite

About The Position

The Senior Regulatory Affairs Specialist drives key regulatory initiatives and contributes to the development and implementation of regulatory strategies to help ensure Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) products are safe, effective, and compliant with global regulatory requirements. This office-based role supports products across their development and lifecycle, with a focus on regulatory strategy for integrated hardware systems and complex device portfolios.

The specialist provides regulatory expertise on 510(k) submissions and CE Marking/EU MDR compliance, and advises cross-functional teams on regulatory considerations for hardware architecture, design inputs, verification, and validation. The role includes leading or supporting international submissions and registrations; maintaining EU MDR technical documentation; supporting conformity assessments and Notified Body interactions; and serving as a regulatory interface during audits and inspections. The position also supports post-market activities and change management, and provides technical leadership and mentoring to Regulatory Affairs colleagues.

The role is office-based and requires residence in or within commuting distance of Cambridge, Massachusetts, or Orange, Ohio. Office-based teams work in person at least three days per week. Travel may be up to 10%. US work authorization is required; sponsorship and relocation benefits are not available.

Requirements

• At least 7 years of Regulatory Affairs experience in FDA-regulated medical device environments.
• Experience with 510(k)s, PMA supplements, CE Marking/EU MDR technical documentation, and pre-submissions.
• Expertise or knowledge in hardware regulations and standards, including IEC 60601; software standards, including IEC 62304; and risk management, including ISO 14971.
• Familiarity with FDA, EU MDR, Health Canada, Japan, and other relevant international regulatory standards, regulations, and submission pathways.
• Ability to build strong relationships with internal and external stakeholders at all levels, share knowledge, provide regulatory insights, and ensure alignment with regulatory requirements.
• Bachelor’s degree in Regulatory Affairs or a scientific or technical discipline.
• Ability to perform the position’s minimum physical, cognitive, and environmental job requirements, with or without accommodation.
• Must reside in or within commuting distance of Cambridge, MA, or Orange, OH.
• US work authorization; candidates requiring work-authorized visa sponsorship now or in the future will not be considered.

Nice To Haves

• Experience with SaMD and IEC 82304.
• Master’s degree.
• RAPS RAC credential.

Responsibilities

• Serve as a regulatory expert for 510(k) and CE Marking/EU MDR compliance, interpreting and applying regulations, guidance, and standards across integrated hardware systems and complex device portfolios.
• Lead and influence global regulatory strategies for market expansion and lifecycle management, including system-level hardware integration considerations for the United States, European Union, Japan, Canada, and other markets as required.
• Provide regulatory guidance to internal stakeholders, including R&D, Quality, Clinical, Marketing, Manufacturing, and Supply Chain, to embed regulatory requirements into hardware system architecture, design inputs, verification, and validation.
• Drive preparation, review, and maintenance of EU MDR technical documentation, including oversight of conformity assessment activities and interactions with Notified Bodies.
• Partner with hardware and systems engineering teams on system-level risk management and hazard analysis, hardware/software interfaces, design changes and impact assessments, and verification and validation strategies for integrated systems.
• Support or lead international regulatory submissions, registrations, and renewals, coordinating submission strategies, gap assessments, and risk mitigation plans.
• Act as a regulatory interface during Notified Body audits, regulatory inspections, and QMS audits, including preparation, participation, and follow-up.
• Provide regulatory input for post-market surveillance, vigilance, and change management to support ongoing product lifecycle compliance.
• Mentor and provide technical leadership to other Regulatory Affairs professionals, supporting capability development and consistent regulatory execution.
• Communicate complex regulatory topics to senior leadership and cross-functional teams to support informed decisions on hardware design tradeoffs and system integration risks.

Benefits

• Generous paid time off.
• 401(k) with up to 7% company match.
• Health Savings Account with company contribution.
• Stock purchase plan.
• Education reimbursement.
• Other benefits through the Philips Total Rewards benefits program.
• An annual incentive bonus, sales commission, or long-term incentives may also be offered.

What This Job Offers

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