Senior Regulatory Affairs Specialist
Vor 4 Tagen
**Senior Regulatory Affairs Specialist - Medical Device**
Xplore Life Science is recruiting for Senior Regulatory Affairs Specialist to join a leading medical device company, that has a global presence. The role is suitable would like to provide and maintain regulatory support, supply regulatory input and data and ensure compliance with standards.
**Responsibilities**
- Ensure compliance to global regulatory requirements and company policies
- Interface and co-ordinate with regulatory agencies; deliver regulatory input and appropriate follow up support to inspections and audits (e.g. FDA, Notified Bodies etc)
- Provide input to the risk management process, procedure improvements, management review and support new product development activities
- Other tasks may be required to support the activities of the Regulatory Affairs department and the Company
**Requirements**:
- Must be fluent in German and English to provide responses to technical queries in either language to authorities/agencies
- 2 - 3 years’ experience in a Regulatory Affairs role in a medical device company
**Why should you apply?**
- You would be the PRRC for Europe, based in the German office, in Berlin
- Offers a hybrid working environment
- The company is established within the medical device industry, with extensive funds and investments
- The salary will range between €80,000 - €90,000
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