Senior Regulatory Affairs Specialist

Philips•Bedford, MA

3d•Hybrid

About The Position

The Senior Regulatory Affairs Specialist plays a critical role in ensuring Philips Image Guided Therapy products are safe, effective, and compliant with applicable global regulatory requirements. This role involves providing regulatory expertise for 510(k) and EU MDR compliance, leading global regulatory strategies, and offering strategic regulatory guidance to internal stakeholders. The specialist will drive the preparation and maintenance of EU MDR Technical Documentation, partner with engineering teams on regulatory assessments, and support international regulatory submissions. Additionally, the role includes acting as a key regulatory interface during audits and inspections, providing input for post-market surveillance, and mentoring other Regulatory Affairs professionals. Clear and effective communication of complex regulatory topics to senior leadership and cross-functional teams is essential.

Requirements

Minimum of 5+ years' experience in Regulatory Affairs within FDA regulated Medical Device environments.
Experience with regulatory approvals and submittal experience-510(k)s, PMA supplements, EU MDR Technical Documents, and pre-submissions.
Detailed knowledge of FDA, EU MDR, Health Canada, Japan and other relevant international regulatory standards, regulations, and submission paths.
Minimum of a Bachelors’ Degree (Required) in Regulatory Affairs, a Scientific or Technical discipline.
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.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

Master’s Degree desired.
RAPs RAC preferred.

Responsibilities

Provide regulatory expertise 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 strategic regulatory 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.