Stellenbeschreibung

R&D - Medical Devices III - Biocompatibility – ISO 10’993 Our client is a Swiss Biotech group headquartered in the Zurich-Zug region. All tasks related to development, production and sales of medical implants are being carried out from the Swiss site. The products are being marketed through nine country affiliates and more than 60 distribution partners worldwide. The company has an exceptionally large R&D department for regenerative medicine and continuously makes significant investments in state-of-the-art technology and equipment. The Clinical and Pre-clinical Affairs department in the Business Unit Biomaterials is recruiting a manager for pre-clinical studies who shall control safety and performance of the concerned products. In this role you develop pre-clinical programs with a special focus on consistent testing of biocompatibility in accordance with legal dispositions and ISO 10‘993/510K for class III medical products. You analyse primary data so as to draw conclusions for pre-submission processes to notified bodies. In addition, you maintain a close contact with relevant opinion leaders, competent authorities and contract research organisations. You negotiate the necessary cooperation contracts and ensure that everything is being done in compliance with guidelines and documentation of the concerned studies. Your profile: M.Sc/PhD degree in life sciences/material sciences Experience in pre-clinical study management for medical devices III Familiar with ISO 10’993 regulatory requirements for MD testing Experience in relationship management with clinical opinion leaders You have strong communication skills - both verbal and written, intellectual agility, and scientific interest. You manage your project independently and adopt a well-structured approach. The existing structure of the team allows you to stand out in your field of competence and to influence significantly all future innovations. Your English is excellent. You also speak German or you are ready to learn it. Then look forward to a pleasant and motivating workplace between city and the Swiss mountains. Interested? We are looking forward to get in touch with you.