Senior Regulatory Affairs Specialist

Regulatory Toolkit; Ohio; On-site; USD 122,000 - 194,000; Full time

Job summary

Philips is seeking a Senior Regulatory Affairs Specialist to drive regulatory initiatives for CT/AMI hardware and software products. You will lead regulatory strategies, ensure global compliance, and collaborate with R&D, Quality, Manufacturing, and other functions to embed regulatory requirements from design input through validation.

You will manage EU MDR documentation, coordinate Notified Body interactions, and support international submissions while mentoring team members.

Qualifications

• 7+ years of Regulatory Affairs experience in FDA-regulated medical devices.
• Experience with 510(k) submissions, PMAs, CE marking/EU MDR technical documents, and pre-submissions.
• Knowledge of hardware (IEC 60601) and software (IEC 62304) regulations.
• Familiarity with FDA, EU MDR, Health Canada, Japan regulatory paths.

Responsibilities

• Provide regulatory leadership across hardware systems and portfolios.
• Drive global regulatory strategy for market expansion and lifecycle management.
• Lead interactions with Notified Bodies and audits.
• Prepare and maintain EU MDR Technical Documentation and conformity assessments.
• Coordinate submissions strategies and risk mitigation plans.

Skills

Regulatory Affairs

510(k) experience

EU MDR

FDA regulations

Risk management ISO 14971

IEC 60601

IEC 62304

SaMD IEC 82304

Regulatory submissions

Leadership

Education

Bachelor's Degree in Regulatory Affairs

Master’s Degree desired

RAC preferred

Job description

Job Title

Senior Regulatory Affairs Specialist

Job Description

The Senior Regulatory Affairs Specialist is responsible for driving key regulatory initiatives contributing to the development and implementation of regulatory strategies, ensuring Philips Computed Tomography (CT)/Advanced Molecular Imaging (AMI) products are safe, effective, and compliant with global regulatory requirements

Your role:

• Serve as a Regulatory expert for 510(k) and CE Mark/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.

You're the right fit if:

• You've acquired a minimum of 7+ years' experience in Regulatory Affairs within FDA regulated Medical Device environments including 510(k)s, PMA supplements, CE Marking/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 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 have a minimum of a Bachelors’ Degree in Regulatory Affairs, a Scientific or Technical discipline. Master’s Degree desired. RAPs RAC preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office-Based role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position inCambridge, MA is $137,000 to $217,000
• The pay range for this position inOrange, OH is $122,000 to $194,000

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related