Global Regulatory Strategy Lead – Medical Devices

Philips; Mission Viejo (CA); Sur place; USD 122 000 - 217 000; Plein temps

Résumé du poste

Philips Senior Regulatory Affairs Specialist drives regulatory strategies for 510(k) and CE Mark/EU MDR, ensuring hardware and system portfolios meet global requirements and remain safe and effective.

You will partner with R&D, Quality, and Marketing to embed regulatory thinking into design inputs, manage EU MDR documentation, lead submissions, audits, and post-market activities, with onsite work and mentoring opportunities.

Qualifications

• 7+ years in Regulatory Affairs in FDA-regulated medical devices.
• Experience with 510(k)s, PMA supplements, CE Marking/EU MDR documents.
• Knowledge of IEC 60601, IEC 62304, ISO 14971; SaMD (IEC 82304) preferred.
• Familiarity with FDA, EU MDR, Health Canada, Japan submission paths.
• Bachelor’s in Regulatory Affairs; Master’s preferred; RAC a plus.

Responsabilités

• Lead global regulatory strategies for 510(k) and CE/EU MDR.
• Embed regulatory requirements into hardware system architecture and design.
• Manage EU MDR Technical Documentation and Notified Body interactions.
• Coordinate international regulatory submissions and renewals.
• Serve as regulatory interface during Notified Body audits and inspections.
• Contribute to post-market surveillance and change management.

Connaissances

Regulatory affairs

FDA regulations

Regulatory strategy

Cross-functional collaboration

Formation

Bachelor's degree in Regulatory Affairs

Master’s degree desired

RAC preferred

Description du poste

Philips Senior Regulatory Affairs Specialist drives regulatory strategies for 510(k) and CE Mark/EU MDR, ensuring hardware and system portfolios meet global requirements and remain safe and effective.

You will partner with R&D, Quality, and Marketing to embed regulatory thinking into design inputs, manage EU MDR documentation, lead submissions, audits, and post-market activities, with onsite work and mentoring opportunities.