Global Medical Devices Regulatory Lead

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

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