Regulatory Compliance Manager
Our client manufactures and distributes high quality patient monitoring and medical surgical consumables. They are aggressively growing and are looking for a regulatory compliance manager to join their team. If you would like to work in a global team who encourages creativity, open for challenges and proactive in finding solutions, this is the perfect opportunity!
- Support in internal and external audits
- Responsible for review, development, remediation and approval of Device History Files and/or Technical Documentation of medical devices according to regulatory requirements (MDR and FDA)
- Regulatory submissions in all markets including license renewal and annual registrations
- Review design changes and support new product design control process with regulatory inputs and decisions
- Evaluate change impacts on products and processes and take regulatory action
- Maintain knowledgeable on regulatory requirements and market changes and support in regulatory strategy planning
- Communication with regulatory agencies
- Support the establishment of quality standards for products, processes, and procedures
- 3+ years professional experience in Medical Device Industry
- Completed medical-technical or scientific university/university of applied sciences studies, or a comparable education
- Thorough knowledge of regulatory requirements such as ISO 13485, CFR, MDR etc.
- Experience in submission of 510(k) premarket notifications, and identifying qualifying devices, PMAs, and CE Technical Documentation
- Good organizational skills, analytical thinking and a high level of reliability
- Fluency in English and German
Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+49 30 1663 7750