Regulatory Affairs Specialist Switzerland
Permanent / Switzerland
Regulatory Affairs Specialist- Medical Devices - office based in Switzerland
Our client is a leading medical device company with offices globally. The company designs, develops and manufactures its own products for the global market.
They are looking for an office based Regulatory Affairs Specialist for their offices in Switzerland
- Prepare international and domestic filings/registrations to established timelines and company objectives
- Coordinate with international contacts on product changes and regulatory notification / approval requirements
- Review and approve product design control documentation
- Review and approve document change orders and prepare letters-to-file
- Ensure applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
- Maintain up-to-date knowledge on international and domestic regulatory requirements
- Support international product registrations and regulatory approvals
- Bachelor's Degree in scientific disipline or equivalent.
- Good oral and written communication with operational management
- 3years of experience in working within Regulatory Department for Medical Devices with FDA or EU or Asia Pacific
- Ability to facilitate and provide leadership when interpreting regulatory standards and guidances
- Good communication with customers, regulatory authorities and approval bodies in Europe
- Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities
510k, FDA , EMEA, CLASS I , CLASS II , CLASS III , Asia Pacific
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email
We regard all communication and correspondence as confidential. Full job descriptions are available on request.