Senior Regulatory Affairs Specialist
Based in Tuttlingen
Our client is a 600 person medical device company with offices in Germany and the USA. For their office in Tuttlingen, they are searching for a candidate to take the position of a Senior Regulatory Affairs Specialist, focusing on worldwide registrations and 510k submissions. The most important is the European MDR where you would be responsible for Class III non-active implants, and Class IIb surgical instruments. The team is currently 6 people in Germany, with a team also in the US and this position reports to the Director of RA/QM. The position offers a competitive salary, 30 days of vacation and bonus. Most importantly - strong development potential for worldwide regulatory approvals for new and existing products.
Managing national and international regulatory submissions. Responsibilities include compiling and sending documentation to distributors / regulators as necessary, and in managing submissions to a successful approval.
Preparation and maintenance of technical documentation for (inter)national product registration
Cooperation with the competent authorities
Coordination and implementation of registrations strategies
Preparation of the documents required for approval
Support of the development department in documentation and regulatory issues
Monitoring of (inter)national regulations and legislative changes
Assist in internal and external audits
Bachelor in Engineering or Science degree (or equivalent) required
2+ years of practical experience in medical technology and regulatory affairs
Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+44 208 638 5376