Global Medical Devices Regulatory Principal Consultant

ProductLife Group; Courbevoie; Presencial; EUR 110.000 - 150.000; Jornada completa

Descripción de la vacante

ProductLife Group seeks a Principal Consultant in Medical Devices Regulatory Affairs and Quality to lead international regulatory projects in Paris. You will advise on market-access strategies and provide technical expertise across medical devices, IVDs, software, and AI-enabled devices.

You will develop regulatory strategies for Europe, the US, and other markets, lead CE marking and FDA submissions, and ensure robust documentation and risk management. English required; French or Italian a plus.

Formación

• 8+ years of experience in medical devices or IVD sectors.
• Master's degree in engineering, pharmacy, biomedical engineering, or related field.
• Strong knowledge of EU MDR 2017/745 and EU IVDR 2017/746.
• Experience with software medical devices and AI-enabled devices.
• Experience with CE marking and international regulatory submissions.
• ISO 13485 audits and MDSAP experience.
• Fluency in English; French or Italian language a plus.
• Ability to lead regulatory projects and provide strategic guidance.

Responsabilidades

• Develop regulatory strategies for Europe, US, and international markets.
• Lead regulatory projects including CE marking and FDA submissions.
• Prepare and maintain technical documentation.
• Support risk management and risk analyses.
• Advise clients from startups to multinational organizations.
• Coordinate and supervise consultants on projects.
• Contribute to internal regulatory expertise and best practices.
• Manage client projects and support business development.

Conocimientos

Regulatory strategy

Project leadership

Client advisory

English proficiency

Educación

Master's degree

Herramientas

EU MDR 2017/745

EU IVDR 2017/746

IEC 60601

IEC 62304

Descripción del empleo

ProductLife Group seeks a Principal Consultant in Medical Devices Regulatory Affairs and Quality to lead international regulatory projects in Paris. You will advise on market-access strategies and provide technical expertise across medical devices, IVDs, software, and AI-enabled devices.

You will develop regulatory strategies for Europe, the US, and other markets, lead CE marking and FDA submissions, and ensure robust documentation and risk management. English required; French or Italian a plus.