Some of your key responsibilities in the role will be:
- Management of 4 direct reports
- Working with R&D and product development to ensure products meet medical device regulatory requirements, on an international scale.
- Ensuring technical documents of products comply with regulatory requirements.
- Responsibility for the regulatory content of product-related information and its release
- Conducting conformity assessment procedures and initiating preparation of the declaration of conformity.
- Audit support and preparation.
You are the ideal candidate if you:
- 3+ years experience in international regulatory affairs for medical devices.
- Management experience.
- Fluent German and English both written and spoken.
- A scientific background in the fields of engineering or medicine.
- Quality Management and product development experience is a benefit.
- Knowledge of MDD 93/42/EEC (product classification, definition of applicable standards, conformity assessment procedures) and other relevant regulations (e.g. the future MDR 2017/745)
- Excellent MS-Office knowledge, experience in handling document control and / or ERP systems (e.g. SAP) is an advantage
Your benefits with the role
- Challenging work in an exciting environment.
- International employer with team-oriented working atmosphere.
- Attractive conditions of employment.
Apply now if you think you could be the next Regulatory Affairs Manager for our client!