Senior Regulatory Affairs Leader, Medical Devices

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

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

510(k) expertise

EU MDR

Regulatory leadership

Risk management

SaMD

Education

Bachelor's in Regulatory Affairs

Job description

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.