Regulatory Affairs Specialist (m / f / d)
Based in Berlin
Our client is a medical technology company with a global presence, listed on the stock exchange with their Headquarters based in Berlin.
They specialize in the development, manufacture and sale of medical devices for the Orthopaedics in the field of trauma including high-risk medical implants to Class III. The team is driven, innovative and focused on being nationally and internationally recognized as a leading medical contributor. The customer-orientated culture raises the standard for medical progress and consistent quality assurance of all products being sold to hospitals, clinics and direct to consumer across 20 countries.
To strengthen the team, a Specialist in Regulatory Affairs is required to support with European approvals of medical devices in a broad, exciting role!
• Implementation of international product approval (for sterile and non-sterile Products EU MDR class Im, Ir, IIa, IIb, III)
• Maintenance of the MDD Technical Documentation and structure / maintenance of the EU MDR Technical Documentation (product file / DHF / DMR)
• Cooperation with the regulatory authorities
• Regulatory support for the development department (Design Projects, Design Changes)
• Support in post market surveillance according to MDD / EU MDR and others international regulations
• At least 2 years of professional experience in a medical technology company (EU class products I to III) in the areas of regulatory affairs and post market surveillance
• Experience in the approval of medical devices with sound knowledge in the field MDD / EU MDR
• Very good knowledge of German and English (oral and written)
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.