The company offers a unique opportunity to combine scientific excellence with commercial success in a future-oriented environment, with innovation and team spirit at its core. A family-friendly company policy, flexible working time models, a wide range of further training opportunities and company health management round off the offer.
Your qualification
- You have completed a technical or scientific degree or comparable training
- You have initial experience in the area of regulatory affairs as well as knowledge of national and international approval procedures.
- You are characterised by a strong service orientation combined with a pleasant, communicative and a structured and reliable way of working.
- Good knowledge of relevant regulations and standards, including Regulation (EU) 2017/745 (MDR), Directive 93/42/EEC (MDD), 21 CFR 820, ISO 13485 as well as initial experience in technical documentation and clinical evaluation are required.
- Very good spoken and written knowledge of German and English as well as very good knowledge of MS Office complete your profile.
Your tasks
- Ensuring compliance with all relevant national and international requirements for the products.
- Responsibility for product approval in specified countries and regular review of existing approvals as well as support of product development from a regulatory perspective.
- Responsible for the creation and maintenance of clinical assessments for medical devices and the creation of technical documentation for medical devices.
- Maintaining communication with authorities, certification bodies and external partners to obtain and maintain approvals and certificates of conformity.
- Work closely with internal teams such as development, product management and quality management to ensure product conformance to required standards.
