Regulatory Affairs Engineer H/F

Company description

Nous sommes une jeune biotech spécialiste de la chirurgie orthopédique de la main et du poignet, la société développe et commercialise en tant que fabricant des implants long terme et des prothèses internes. L’innovation et la qualité sont les valeurs de base de la société.

La société consacre une part très importante de son chiffre d'affaire à la recherche et au développement de nouveaux produits.

Basée en Suisse à Genève ses activités couvrent le monde (Europe, Canada, USA, …)

Job description

Reporting directly to general management, you are responsible for the company’s quality policy and your missions are :

Notified Body’s relationship management (approvals, audits, ...)
Verification / Establishment of technical and design files with the R & D manager
Follow-up of process validation, cleaning, sterilization, ... with the industrialization manager
Establishment and update of biocomp and clinical data with the R & D manager
Getting and managing CE markings by implants
Preparation and follow-up of FDA files (510k and PMA), with the US consultant
Management of FDA approvals

Profile

Graduated, you have at least five years experience in leading quality projects in the Biotechnology industry, preferably at an orthopedic implant manufacturer. You have excellent knowledge of ISO 13485 standards and procedures, CE marking and 510k files.

Excellent interpersonal relationships is essential to this position. A good level in English is essential. Finally, you are pragmatic, have an entrepreneurial spirit and want to invest in a human-scale structure developing internationally.

Permanent position based in Geneva in a pleasant setting. An attractive remuneration, according to the candidate's experience, will be proposed.