Ra manager

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

To complete our team based in Mont-sur-Lausanne, we are looking for a Regulatory Affairs Manager.

RA Manager

Your responsibilities

- Define and deploy the regulatory strategy for international markets
- Ensure the compliance of medical devices according to applicable regulations (MDR 2017/745, FDA, ISO 13485, etc.)
- Prepare, maintain and submit regulatory dossiers
- Interact with competent authorities, notified bodies and external partners
- Participate in change control activities and regulatory impact assessments
- Collaborate closely with Quality, R&D, Clinical and Marketing teams
- Ensure proactive regulatory monitoring and support internal teams on regulatory matters
- Supervise, support and develop the Regulatory Affairs team
- Organise priorities, allocate activities and ensure 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
- Proven experience (minimum 5 years) in regulatory affairs applied to medical devices (class II and III, implantable)
- Successful experience in management or coordination of RA teams
- Good knowledge of the European MDR regulation and associated quality standards
- Experience with international submissions appreciated
- Fluent in French and English, both written and spoken
- Leadership, rigour and excellent communication and organisational skills

We offer

- A dynamic and innovative environment within the MedTech sector
- High value-added international projects
- A strategic role with managerial responsibilities
- A collaborative culture focused on continuous improvement
- Attractive conditions and career development prospects

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