Regulatory Affairs Manager

About the job

Regulatory Affairs Manager (M/F)

Regen Lab SA has been dedicated since 2003 to the production of medical devices for the preparation of autologous blood derivatives (PRP), intended for non-haematological therapeutic applications in the fields of sports medicine, rheumatology, orthopaedic surgery, urology, aesthetic medicine, and wound treatment.

To strengthen our team based in Mont-sur-Lausanne, we are looking for a Regulatory Affairs Manager with solid regulatory expertise, capable of managing regulatory activities while directly contributing to their operational execution.

Your responsibilities

• Define, deploy and implement the regulatory strategy for international markets.
• Ensure the compliance of medical devices with applicable regulations and standards, notably the European MDR 2017/745 regulation, FDA requirements, and ISO 13485 standard.
• Prepare, write, update and maintain the technical and regulatory files necessary for the registration and maintenance of medical devices on various markets.
• Carry out a significant amount of document writing, including technical files, regulatory reports, conformity justifications, and associated documents.
• Manage Post-Market Surveillance (PMS) activities and contribute to the preparation, writing, and updating of Periodic Safety Update Reports (PSUR), in accordance with applicable regulatory requirements.
• Monitor registrations, submissions, and regulatory renewals on the relevant markets.
• Interact with competent authorities, notified bodies, and external partners.
• Participate in change control activities and conduct regulatory impact assessments related to product, process, or documentation changes.
• Work closely with Quality, R&D, Clinical, and Marketing teams to integrate regulatory requirements throughout the medical device lifecycle.
• Ensure proactive regulatory monitoring and support internal teams in understanding and applying current requirements.
• Supervise, support, and develop the Regulatory Affairs team, organise priorities and allocate activities ensuring compliance with regulatory deadlines.
• Contribute to recruitment, training, and skills development of the team.

Your profile

• Scientific or engineering education, ideally complemented by a specialisation in regulatory affairs.
• At least 5 years of experience in regulatory affairs in the medical device sector, ideally class II and III devices, including implantables.
• Proven experience in preparing and maintaining technical and regulatory files.
• Practical experience in PMS and PSUR, including writing and updating associated reports.
• Excellent writing skills and ability to produce structured, precise regulatory documentation compliant with applicable requirements.
• Strong knowledge of the European MDR 2017/745 regulation and associated quality standards.
• Experience with international regulatory submissions and FDA requirements is appreciated.
• Experience in management or coordination of a Regulatory Affairs team.
• Fluent in French and English, both written and spoken.
• Autonomy, rigour, organisational skills, and ability to manage multiple files simultaneously.
• Pragmatic mindset, proactivity, and ability to reconcile strategic vision, technical expertise, and operational involvement.

We offer

• A dynamic and innovative environment within the MedTech sector.
• High value-added international projects.
• A role combining regulatory expertise, managerial responsibilities, and direct operational involvement.
• A key role in maintaining regulatory compliance and the international development of our medical devices.
• A collaborative culture focused on continuous improvement.
• Attractive conditions and career development prospects.