Global Regulatory Affairs Lead, Medical Devices

Regulatory Jobs; 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

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.