Senior Regulatory Affairs Specialist

Philips

. Drive key regulatory initiatives contributing to the development and implementation of regulatory strategies .

Posted 10/27/2026full-timeUnited StatesSenior💰 $122,000 - $217,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a focus on compliance for Medical Devices, including 510(k), CE Marking, and EU MDR. Proven ability to lead regulatory strategies, mentor professionals, and communicate complex topics effectively across cross-functional teams.

Highest-signal resume keywords

Regulatory Affairs Expertise510(k) ComplianceEU MDR Technical DocumentationIEC 60601 KnowledgeStakeholder Relationship Building

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRisk Management (ISO 14971)SaMD Familiarity (IEC 82304)Conformity Assessment OversightInternational Regulatory Submissions

Soft Skills

MentoringCommunicationInfluencing

Tools & Technologies

Notified Bodies InteractionQMS Audits

Certifications & Qualifications

RAPs RACBachelor's Degree in Regulatory AffairsMaster's Degree (Desired)

Industry Keywords

FDA RegulationsEU MDRHealth Canada StandardsMedical Device ComplianceMarket Expansion Strategies

About the role

Key responsibilities & impact

Drive key regulatory initiatives contributing to the development and implementation of regulatory strategies
Ensure Philips Computed Tomography and Advanced Molecular Imaging products are safe, effective, and compliant with global regulatory requirements
Serve as regulatory expert for 510(k) and CE Mark/EU MDR compliance
Lead and influence global regulatory strategies for market expansion and lifecycle management
Provide regulatory guidance to R&D, Quality, Clinical, Marketing, Manufacturing, Supply Chain, and other stakeholders
Drive preparation, review, and maintenance of EU MDR Technical Documentation
Oversee conformity assessment activities and interact with Notified Bodies
Support hardware and systems engineering assessments covering risk management, hardware/software interfaces, design changes, and verification and validation
Lead or support international regulatory submissions, registrations, and renewals
Coordinate submission strategies, gap assessments, and risk mitigation plans
Act as regulatory interface during Notified Body audits, regulatory inspections, and QMS audits
Provide regulatory input for post-market surveillance, vigilance, and change management
Mentor Regulatory Affairs professionals and support capability development
Communicate complex regulatory topics to senior leadership and cross-functional teams

Requirements

What you’ll need

Minimum of 7+ years' experience in Regulatory Affairs within FDA-regulated Medical Device environments
Experience with 510(k)s, PMA supplements, CE Marking/EU MDR Technical Documents, and pre-submissions
Expertise/knowledge in IEC 60601 for hardware, IEC 62304 for software, and ISO 14971 for risk management
Experience with SaMD (IEC 82304) preferred
Familiarity with FDA, EU MDR, Health Canada, Japan, and other international regulatory standards, regulations, and submission paths
Ability to build strong relationships with internal and external stakeholders at all levels
Minimum of a Bachelor's Degree in Regulatory Affairs, a Scientific, or Technical discipline
Master's Degree desired
RAPs RAC preferred
US work authorization required; candidates requiring sponsorship now or in the future will not be considered
Must reside in or within commuting distance to Cambridge, MA or Orange, OH
Ability to meet minimum physical, cognitive, and environmental job requirements with or without accommodation
May travel up to 10%

Benefits

Comp & perks

Annual incentive bonus may be offered
Sales commission may be offered
Long-term incentives may be offered
Generous PTO
401k with up to 7% match
HSA with company contribution
Stock purchase plan
Education reimbursement
Comprehensive Philips Total Rewards benefits program