Principal Consultant

ProductLife Group; Courbevoie; On-site; EUR 110,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory strategy

Project leadership

Client advisory

English proficiency

Education

Master's degree

Tools

EU MDR 2017/745

EU IVDR 2017/746

IEC 60601

IEC 62304

Job description

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

Job Description

We are looking for a Principal Consultant in Medical Devices Regulatory Affairs and Quality to join our team in Paris. You will lead international regulatory and quality projects, advise clients on market‑access strategies, and provide technical expertise across medical devices, IVDs, software, and AI-enabled medical devices.

Responsibilities

• Develop and propose regulatory strategies for Europe, the United States, and other international markets
• Lead regulatory projects, including CE marking, FDA 510(k) submissions, and international registrations
• Prepare, review, and maintain technical documentation
• Support risk management and risk‑analysis activities
• Advise a wide range of clients, from start‑ups to large international organizations
• Support remediation activities and interactions with Notified Bodies
• Provide regulatory expertise for software medical devices, SaMD, and AI‑enabled medical devices
• Support the compliance of electromedical devices with applicable IEC 60601 requirements
• Conduct Quality Management System audits in accordance with ISO 13485
• Support MDSAP audits and readiness assessments
• Perform regulatory and quality due diligence for acquisitions, investments, licensing agreements, and strategic partnerships
• Identify compliance gaps, assess associated risks, and define remediation plans
• Manage client projects and contribute to business‑development activities
• Coordinate and supervise consultants, depending on experience
• Contribute to the development of internal regulatory expertise and best practices

Experience

• Master's degree or equivalent, ideally in engineering, pharmacy, biomedical engineering, quality, regulatory affairs, or another scientific or technical discipline
• At least 8 years of experience in the medical device and/or IVD industry
• Strong knowledge of EU MDR 2017/745 and/or EU IVDR 2017/746
• Very good knowledge of IEC 62304 and medical device software lifecycle requirements
• Experience with software medical devices and/or AI‑enabled medical devices
• Experience preparing and reviewing technical documentation for CE marking
• Experience with international regulatory submissions, particularly in the United States, would be a strong advantage
• Knowledge of electromedical devices and the IEC 60601 series would be highly valued
• Experience with ISO 13485 audits and MDSAP would be an advantage
• Professional proficiency in English
• Fluency in French or Italian