What you will be doing
- Translate regulatory landscape to product specific action plans (e.g. MDR IIa, FDA 21 CFR 820)
- Evaluate product specific risk management
- Contribute all regulatory aspects to technical documentation (jointly with QM)
- Manage certification process
- Oversee/ do post-market surveillance
What you will bring to the table
- Minimum bachelor degree in science or engineering
- > 5 years of regulatory experience in the medical device industry, preferably with medical software
- Comprehensive regulatory knowledge, e.g. guidelines, policies, applicable product laws/standards
- Strong project management experience, especially with supporting new product developments and launches
- Fluency in English and German
The ideal candidateWe are looking for a Senior Regulatory Manager who wants to make a difference.
What we can offerWith our digital products, we accompany patients on their individual path to personal health and help them to achieve the best possible therapy results. Health and well-being is also very important to us for our employees.
- We are an open, motivated and international team
- We believe in you - you get maximum responsibility and trust from day one
- We practice a fair feedback culture so that everyone can fully exploit their potential
- We are working goal driven and live our shared values
- We organize regular team events, provide you with delicious coffee, snacks and smoothies and have a really cozy office
Benefits at Temedica
We believe in you. That's why we give you maximum responsibility and trust from day one.
We think it is essential to engage in lively dialog and give feedback based on a culture of fairness.
We work determinedly toward achieving our goals, and we embody our common values.
Here you“ll get fantastic coffee, snacks and, of course, a great place to work.