Senior Regulatory Affairs Specialist

Philips; Cambridge (MA); Presencial; USD 137 000 - 217 000; Tempo integral

Resumo da oferta

Philips in Cambridge, MA is seeking a Senior Regulatory Affairs Specialist to drive regulatory initiatives for CT/AMI hardware. You will lead 510(k) and EU MDR activities, interact with Notified Bodies, and influence design inputs for compliant hardware systems across the US, EU, and other markets.

You will collaborate with R&D, Quality, Clinical, and Manufacturing to ensure regulatory requirements are embedded in every stage of development, verification, and lifecycle management.

Qualificações

• Minimum 7+ years in Regulatory Affairs within FDA-regulated medical devices.
• Experience with 510(k)s, PMA supplements, CE Marking/EU MDR Technical Documentation, and pre-submissions preferred.
• Familiarity with hardware (IEC 60601), software (IEC 62304), ISO 14971, and IEC 82304 for SaMD is desirable.

Responsabilidades

• Drive regulatory strategies for Philips CT/AMI products globally.
• Lead EU MDR technical documentation and Notified Body interactions.
• Collaborate with R&D, Quality, Clinical, and Manufacturing to embed regulatory requirements in hardware design and verification.
• Support regulatory submissions, registrations, renewals, and audits; participate in Notified Body audits and inspections.
• Provide regulatory input for post-market surveillance and change management; mentor junior staff.

Conhecimentos

Regulatory affairs

510(k) expertise

EU MDR

Regulatory leadership

Risk management

SaMD

Formação académica

Bachelor's in Regulatory Affairs

Descrição da oferta de emprego

Senior Regulatory Affairs Specialist# Careers## Senior Regulatory Affairs SpecialistApply: Orange (OH), Ohio, United States: Cambridge (US), Massachusetts, United States: Full time: Posted Today: 593637### Job TitleSenior Regulatory Affairs Specialist### Job DescriptionThe 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 in***Cambridge, MA*** **is $137,000 to $217,000*** The pay range for this position in***Orange, 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 knowledge/skills, experience, business needs, geographical location, and internal equity.** In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found**here****.** **Additional Information:** * **US work authorization is a precondition of employment**. The company***WILL NOT** consider candidates who require sponsorship for a work-authorized visa*, now or in the future.* Company relocation benefits***WILL NOT***be provided for this position**. For this position, you MUST reside in or within commuting distance to** ***Cambridge, MA*** o***r Orange, OH.**** **May travel up to 10%** **#LI-PH1**This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.*Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.*