Found Description
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...