Careers » Regulatory Affairs Manager – Medical Devices
Become part of an interesting company in the biotechnology industry. Join us in improving people’s lives in a sustainable way. Get to know the advantages of a smaller company embedded in a global corporation. We offer you a wide range of tasks in an innovative, attractive and interesting work environment, a friendly team, opportunities for continued development and performance-related compensation.
We are looking for a Regulatory Affairs Manager – Medical Devices to handle the creation and maintenance of technical and development documentation for medical devices.
Essential Job Functions
- You handle the creation and maintenance of technical and development documentation for medical devices.
- You are responsible for document preparation of medical device conformity assessment procedures
- You support development projects with regard to regulatory requirements and communicate with the relevant authorities.
- You are responsible for the further development and optimization of processes
- You assist with applications for marketing authorizations for medicinal products
- You handle complaints regarding medical devices
- You bring with you strong teamwork and communication skills
- You bring initiative, are reliable and structured
- You recognize problems and are solution-oriented
- Degree in natural sciences or technical studies, such as medical technology, biotechnology, industrial engineering or comparable qualifications
- Two years of professional experience in the field of regulatory affairs and medical technology
- Knowledge in the area of medical device certification according to MDD and/or MDR
- Knowledge in the area of QM according to ISO 13485
- Good English and PC skills (MS-Office, SAP is an advantage)
About the Company
Setting new standards in regenerative medicine.
TETEC AG is a company in the biotechnology sector and belongs to the global corporation B. Braun. At our site in Reutlingen, we develop and produce innovative products for the treatment of complex damage and diseases in the area of human musculoskeletal system. TETEC consists of around 140 employees, each of whom is organized into interdisciplinary teams. We bring together specialists from various disciplines and uniquely combine cell and molecular biological knowledge with clinical and pharmacological know-how.