Regulatory Affairs Manager (m/w/d)
The location specified in the vacancy (Aschau, Erfurt or remote) is discussed based on where the candidate lives. Initial training lasts 6 weeks and is held at the main site.
Your field of activity - demanding
- Implementation of the MDR 2017/745, associated guidelines and standards
- Creating and maintaining technical documentation for existing products and new developments.
- Communicating with the responsible approval authorities and notified bodies
- Carrying out conformity assessment procedures
- Keeping up with developments in the field of regulatory requirements and implementing measures to meet them
- Supporting the creation and development of sales-supporting materials (product brochures etc.).
- Close cooperation with the sales and marketing team as well as regular meetings with related departments
- Building up product-specific expertise and passing on that knowledge into the company
Your requirements - qualified
- Completed studies in the field of medical technology ,industrial engineering or product engineering or a comparable qualification.
- Experience in project management is an advantage
- Very good understanding of applications and resulting customer requirements
- Knowledge of the standards governing medical technology
- Strong customer orientation
- Pragmatic and analytical approach
- Confidence and assertiveness
We offer - charming
As a reliable employer we support our Königsee team with a host of prospects and flexible offers for all phases in life. Discover us:
- A structured and detailed initiation at the company sites where a mentor will support you.
- Varied and responsible tasks including decision pathways and a flat hierarchy
- A future-proof and permanent job in a growing company
- A family-oriented and social personnel policy, incorporating flexible working hours, for instance, ensures a healthy work-life balance
- Sustainability and responsibility for future generations is incorporated into the day-to-day running of the business
- Open company structure
- Free parking
- Water dispensers
- Monthly vouchers
- Company pension
- …. And much more