Senior Regulatory Affairs Specialist

Philips • Orange, OH

1d • $122,000 - $217,000 • Onsite

About The Position

The Senior Regulatory Affairs Specialist drives regulatory initiatives and contributes to regulatory strategy development and implementation to help ensure Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) products are safe, effective, and compliant with global requirements. This office-based role supports market expansion and product lifecycle management across the United States, European Union, Japan, Canada, and other international markets as needed.

The specialist provides regulatory expertise and strategic guidance across functions, with a focus on integrated hardware systems and complex device portfolios. The role includes EU MDR technical documentation and conformity assessment, international submissions and registrations, audit and inspection support, post-market compliance, and regulatory assessments involving system risks, hardware/software interfaces, design changes, and verification and validation. The position also provides technical leadership and mentorship to Regulatory Affairs colleagues.

The position is based in or within commuting distance of Cambridge, Massachusetts, or Orange, Ohio. Office-based employees work in person at least three days per week. Travel may be up to 10%. US work authorization is required, and relocation benefits are not provided.

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 Documents, 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 regulations, standards, and submission pathways.
• Ability to build relationships with internal and external stakeholders at all levels, share knowledge and 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 requirements, with or without accommodation.
• US work authorization; sponsorship is not available now or in the future.
• Must reside in or within commuting distance of Cambridge, MA, or Orange, OH.

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 Mark/EU MDR compliance, interpreting and applying regulations, guidance, and standards across hardware systems and device portfolios.
• Lead and influence global regulatory strategies for market expansion and lifecycle management in the United States, European Union, Japan, Canada, and other international markets.
• Advise internal stakeholders, including R&D, Quality, Clinical, Marketing, Manufacturing, and Supply Chain, so regulatory requirements are incorporated into hardware architecture, design inputs, verification, and validation.
• Drive preparation, review, and maintenance of EU MDR Technical Documentation, including conformity assessment oversight and interactions with Notified Bodies.
• Partner with hardware and systems engineering teams on regulatory assessments of system-level risk management and hazard analysis, hardware/software interfaces, design changes and impact assessments, and integrated-system verification and validation strategies.
• Support or lead international regulatory submissions, registrations, and renewals, coordinating submission strategies, gap assessments, and risk-mitigation plans.
• Serve as a key 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 maintain 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 to senior leadership and cross-functional teams to support informed decisions about hardware design tradeoffs and system integration risks.

Benefits

• Generous PTO
• 401(k) with up to 7% match
• HSA with company contribution
• Stock purchase plan
• Education reimbursement
• Comprehensive Philips Total Rewards benefits program
• Annual incentive bonus, sales commission, or long-term incentives may be offered

What This Job Offers

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