Principal Consultant, Medical Devices Regulatory & Quality

ProductLife Group; Paris; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

ProductLife Group in Paris seeks a Principal Consultant in Medical Devices Regulatory Affairs and Quality to lead international regulatory projects and advise clients on market-access strategies.

You will provide technical expertise across medical devices, IVDs, software and AI-enabled devices, and supervise consultants on regulatory deliverables and audits.

Qualifications

• Master’s degree or equivalent in engineering, pharmacy, biomedical engineering, quality, regulatory affairs or similar.
• 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 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, especially in the United States.
• Fluency in English; French or Italian language skills are highly valued.

Responsibilities

• Develop and propose regulatory strategies for Europe, the United States and other 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 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 IEC 60601 compliance for electromedical devices and conduct ISO 13485 audits and MDSAP readiness.
• Perform regulatory and quality due diligence for acquisitions, investments, licensing agreements and partnerships.
• Identify gaps, define remediation plans, and manage client projects with consultants.

Skills

Regulatory affairs

Quality management

Project leadership

Client advisory

English proficiency

French or Italian language

Education

Master’s degree or equivalent

Job description

Principal Consultant, Medical Devices Regulatory & Quality

Paris

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Hybrid

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Medical Device and MedTech Services

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Permanent contract

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