Senior Regulatory Affairs Specialist (m/w/d)

Ihre Aufgaben

As a Senior Regulatory Affairs Specialist, you will work closely with all departments and be mainly responsible to prepare / review and maintain the technical documentation according MDR 2017/745 (EU) and preparation, review and maintenance as well as submissions for international approval.

• Responsible for the creation, review and maintenance of technical documentation
• Responsible for preparation, review and maintenance as well as supporting of submissions for international approval, for re-registration activities and for the internal communication in view of international regulatory related changes
• Support and guidance of other department for Medical Software and Cybersecurity 
• Support Clinical Evaluation, Vigilance / Post-Marketing Surveillance activities 
• Contribution to risk assessments
• Support in the creation and handling of Manufacturer Information (IFU, Labels, Brochure, Website, UDI)
• Support during ...