JOB TITLE: Director of European Medical Device Regulation
We need to strengthen our Quality and Regulatory Affairs organization with a Director of European MDD. The position purpose is to ensure that all quality systems are in compliance with the European Medical Device Regulation and regional regulations for all countries affected within our company.
As the Director of European Medical Device Regulation you are the official contact person for Regional authorities for quality system regulation as well as for incident handling and reporting. You need to ensure compliance with the FDA quality system regulation for the entire European market.
You are the official representative in CE-registering products in the authority register and the official representative in environmental contacts with authorities, which includes that you issue annual environmental reports to authorities. As the Director you conduct regular internal audits within our company and you produce Management Review reports to SVP Group Quality.
You are responsible for global reporting to authorities and for the follow up on those reports. Furthermore you are responsible for supporting the quality system strategy within the company and for the product registrations at authorities. You are also responsible for Vigilance Committee and support 510k approval process as needed
The position reports to the SVP Quality and Regulatory Affairs and as the organization grows, direct reports may be established.
- Master of Science in Quality or equivalent education.
- broad technical and regulatory knowledge in the medical device area and experience in running quality systems and especially for the medical device area.
- Manage contacts and communications with authorities as well as in reading and understanding how to interpret standards, regulations, norms etc.
- To be successful in this position we believe that you are accurate and able to stand stress.
- problem solving skills due to the fact that all unsolved final company question regarding quality ends up at the desk of this position.