We are a young biotech specialised in hand and wrist orthopedic surgery, the company develops and sells as a manufacturer long-term implants and internal prostheses. Innovation and quality are the basic values of society.
The company dedicates a very significant part of its turnover to the research and development of new products.
Based in Switzerland in Geneva, its activities cover the world (Europe, Canada, USA, ...)
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
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.