Principal Consultant

ProductLife France; Courbevoie; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid & flexible working

Continuous learning

Job summary

ProductLife Group is seeking a Principal Consultant in Medical Devices Regulatory Affairs and Quality to join our team in Paris. The role leads regulatory strategy across Europe, the US and other markets, overseeing CE marking, FDA submissions, and documentation while guiding clients from startups to multinational entities.

You will manage risk, contribute to QMS activities, and supervise consultants, with a focus on software devices and AI-enabled medical devices in a dynamic, international

Qualifications

• Master's degree or equivalent in science/engineering, pharmacy, or regulatory fields.
• Minimum 8 years of experience in medical devices and/or IVD.
• Strong knowledge of EU MDR 2017/745 and EU IVDR 2017/746.
• Familiarity with IEC 62304 and software lifecycle requirements.
• Experience with CE marking documentation and regulatory submissions.
• Experience with international submissions (US) is advantageous.
• English proficiency; French or Italian is a plus.

Responsibilities

• Develop regulatory strategies for Europe, the US and international markets.
• Lead regulatory projects including CE marking and FDA submissions.
• Prepare, review, and maintain technical documentation.
• Support risk management and risk analysis activities.
• Advise clients from startups to international organizations.
• Coordinate and supervise consultants on projects.
• Contribute to internal regulatory expertise and best practices.
• Support MDSAP audits and readiness assessments.

Skills

Regulatory strategy

Regulatory leadership

Regulatory submissions

Quality management

MDSAP audits

FDA submissions

Software medical devices

AI-enabled devices

Education

Master's degree or equivalent in science/engineering

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.

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

PLG partners with Life Sciences innovators to bring new medicines and technologies to patients, faster. Join a fast-growing, entrepreneurial company where your expertise makes a difference from day one. A path for every career stage, from graduate to senior expert Exciting, high-impact projects with leading life sciences clients International by design Hybrid & flexible working Continuous learning An inclusive & diverse culture