Senior Regulatory Lead, Medical Devices & Quality

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

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.