Senior Regulatory Lead, Medical Devices

PharmaLex; Paris; On-site; EUR 90,000 - 120,000; Full time

Job summary

PharmaLex France SAS is seeking a Senior Manager, Regulatory Affairs - Medical Device to lead regulatory development and project delivery for medical devices and drug-device combinations. You will guide teams, interact with clients and health authorities, and drive high-quality regulatory strategies.

The role emphasizes leadership in regulatory affairs, client service, and cross-functional collaboration to ensure timely, compliant project outcomes across diagnostics and device spaces.

Qualifications

• Proven, in-depth experience in regulatory affairs for medical devices or related field.
• Strong expertise in medical technology and veterinary products.
• Experience supporting medical advice activities is essential.
• Excellent understanding of client needs and business context.

Responsibilities

• Lead planning and execution of client projects with KPIs, timelines and budgets.
• Coordinate project teams locally and with external partners.
• Provide regulatory and strategic guidance to clients on medical device matters.
• Engage with Health Authorities and manage regulatory submissions.
• Prepare and review project documentation within assignments.
• Support business development and staff capability building.

Skills

Regulatory leadership

Project management

Communication skills

Stakeholder management

Education

University degree in Science or Engineering

Job description

PharmaLex France SAS is seeking a Senior Manager, Regulatory Affairs - Medical Device to lead regulatory development and project delivery for medical devices and drug-device combinations. You will guide teams, interact with clients and health authorities, and drive high-quality regulatory strategies.

The role emphasizes leadership in regulatory affairs, client service, and cross-functional collaboration to ensure timely, compliant project outcomes across diagnostics and device spaces.