Principal Consultant

PLG; Paris; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

ProductLife Group is seeking a Principal Consultant in Medical Devices Regulatory Affairs and Quality to lead international regulatory projects from Paris. You will guide regulatory strategies, submissions, and technical documentation for medical devices, IVDs, software, and AI-enabled devices while coordinating with clients and Notified Bodies.

Ideal candidates have 8+ years in the industry, deep EU MDR/IVDR and IEC 62304 knowledge, and strong English; French or Italian is a plus.

Qualifications

• Master's degree or equivalent in engineering, pharmacy, biomedical engineering, quality, regulatory affairs or related field.
• At least 8 years of experience in medical devices and/or IVD industries.
• Strong knowledge of EU MDR 2017/745 and EU IVDR 2017/746.
• Excellent knowledge of IEC 62304 and software life cycle requirements.

Responsibilities

• Develop regulatory strategies for Europe, the US and international markets.
• Lead regulatory projects including CE marking and FDA submissions; manage international registrations.
• Prepare, review and maintain technical documentation.
• Support risk management and risk-analysis activities.
• Advise 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 devices.
• Ensure IEC 60601 compliance for electromedical devices.
• Conduct ISO 13485 audits and support MDSAP readiness.
• Perform regulatory and quality due diligence for acquisitions and partnerships.
• Identify compliance gaps and remediation plans; manage client projects and business development.

Skills

Regulatory affairs

Quality management

CE marking

FDA submissions

EU MDR 2017/745

EU IVDR 2017/746

IEC 62304

MDSAP

AI-enabled medical devices

English proficiency

Education

Master's degree

Job description

## Principal ConsultantApply: Hybrid: Courbevoie Office: Full time: Posted 11 Days Ago: JR000037Make 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 ItalianReady to take the next step? Apply today and join a global, innovative team that’s shaping the future of life sciences and empowering people to make a real impact in healthcare.