You are thrilled to work for a company with high ethical values and would love to have an immense impact on people’s lives by helping release our products? As our Senior Regulatory Affairs Specialist (m/f/d) you’ll take ownership our Regulatory topics in a very critical role to the company’s future and help fulfil relevant national and international regulatory requirements in cooperation with our team.
- You plan, coordinate and complete national and international medical device certification application processes and register our products in cooperation with our Product & Technology Teams
- Together with our Regulatory Team you are responsible for the certification process from approval strategy to documentation, in line with the medical device certification requirements (e.g. ISO standards, IVDR, FDA,)
- You take care of the technical leadership in our interdisciplinary project teams for product approval as representative of our Regulatory Team
- You maintain and review existing technical product files, e.g. for up-to-dateness and compliance
- You identify / foresee regulatory requirements and changes (up-to-date regulatory strategy, reaching strategy goals)
- You take care of product-related risk management, from systematically identifying the current state-of-the-art to post-release risk analysis as part of
- You make sure that our products comply with all applicable global and regional regulatory requirements from labeling over performance to safety elements