Global Regulatory Lead - Medical Devices (510(k)/EU MDR)

Philips; Cambridge (MA); On-site; USD 137,000 - 217,000; Full time

Benefits offered by this job

Paid time off

401(k) with company match

Health Savings Account contributions

Stock purchase plan

Education reimbursement

Job summary

Philips in Cambridge, MA seeks a Senior Regulatory Affairs Specialist to lead regulatory strategies for 510(k) and EU MDR across advanced imaging hardware. You will partner with R&D, Quality, and Manufacturing to embed regulatory requirements into design and ensure global compliance.

You will coordinate Notified Bodies, submissions, and post-market activities, while mentoring junior staff and communicating complex topics to senior leadership. This is an office-based role with travel up to 10%.

Qualifications

• 7+ years of experience in Regulatory Affairs within FDA-regulated medical devices, including 510(k), CE Mark, and EU MDR.
• In-depth knowledge of hardware (IEC 60601), software (IEC 62304), risk management (ISO 14971), and SaMD guidance.
• Experience coordinating global submissions and liaising with Notified Bodies and health authorities.
• Bachelor's Degree in Regulatory Affairs or related field; Master’s degree preferred; RAP RAC preferred.

Responsibilities

• Serve as regulatory expert for 510(k) and CE Mark/EU MDR compliance across hardware systems.
• Lead global regulatory strategies to support market expansion and lifecycle management.
• Provide regulatory leadership to R&D, Quality, and Manufacturing to embed requirements in design.
• Prepare and maintain EU MDR Technical Documentation and interact with Notified Bodies.
• Support international regulatory submissions and audits, including Notified Body and QMS.
• Mentor regulatory professionals and communicate complex topics to leadership.

Skills

Regulatory Affairs

Lifecycle management

Regulatory strategy

Education

Bachelor's Degree in Regulatory Affairs

Master’s Degree (preferred)

Job description

Philips in Cambridge, MA seeks a Senior Regulatory Affairs Specialist to lead regulatory strategies for 510(k) and EU MDR across advanced imaging hardware. You will partner with R&D, Quality, and Manufacturing to embed regulatory requirements into design and ensure global compliance.

You will coordinate Notified Bodies, submissions, and post-market activities, while mentoring junior staff and communicating complex topics to senior leadership. This is an office-based role with travel up to 10%.