10 Jun

RA Manager

Vaud

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 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