Senior Regulatory Affairs Specialist

Philips; Orange (OH); Presencial; USD 120 000 - 160 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Conhecimentos

Regulatory expertise

510(k) compliance

EU MDR

Cross-functional collaboration

Descrição da oferta de emprego

Job Title

Senior Regulatory Affairs Specialist

Job Description

The Senior Regulatory Affairs Specialist is responsible for driving key regulatory initiatives contributing to the development and implementation of regulatory strategies, ensuring Philips Computed Tomography (CT)/Advanced Molecular Imaging (AMI) products are safe, effective, and compliant with global regulatory requirements

Your role:

• Serve as a Regulatory expert for 510(k) and CE Mark/EU MDR compliance, including interpretation and application of regulations, guidance, and standards across integrated hardware systems and complex device portfolios.
• Lead and influence global regulatory strategies to support market expansion and lifecycle management, with emphasis on system-level hardware integration considerations for US, EU, Japan, Canada, and other international markets as required.
• Provide regulatory leadership and strategic guidance to internal stakeholders (R&D, Quality, Clinical, Marketing, Manufacturing, Supply Chain, etc.) to ensure regulatory requirements are embedded into hardware system architecture, design inputs, verification, and validation activities.
• Drive preparation, review, and maintenance of EU MDR Technical Documentation, including oversight of conformity assessment activities and interactions with Notified Bodies.