Global Regulatory Affairs Lead – Medical Devices

Philips; Orange (OH); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Philips Senior Regulatory Affairs Specialist plays a key role in driving regulatory initiatives for CT/AMI hardware, ensuring compliance with global regulatory requirements.

You will lead 510(k) and EU MDR strategies, coordinate with R&D, QA,Clinical, Marketing, Manufacturing, and Supply Chain to embed regulatory considerations into hardware design and lifecycle management.

This role spans US, EU, Japan, Canada and other markets, supporting market expansion and cross-border regulatory activities.

Formación

• Minimum knowledge of US 510(k) and EU MDR requirements.
• Experience aligning hardware system design with regulatory standards.
• Ability to lead regulatory strategies across multiple markets.

Responsabilidades

• 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 internal stakeholders (R&D, Quality, Clinical, Marketing, Manufacturing, Supply Chain).
• Drive preparation, review, and maintenance of EU MDR Technical Documentation and interactions with Notified Bodies.

Conocimientos

Regulatory expertise

510(k) compliance

EU MDR

Cross-functional collaboration

Descripción del empleo

Philips Senior Regulatory Affairs Specialist plays a key role in driving regulatory initiatives for CT/AMI hardware, ensuring compliance with global regulatory requirements.

You will lead 510(k) and EU MDR strategies, coordinate with R&D, QA,Clinical, Marketing, Manufacturing, and Supply Chain to embed regulatory considerations into hardware design and lifecycle management.

This role spans US, EU, Japan, Canada and other markets, supporting market expansion and cross-border regulatory activities.