Regulatory Affairs Manager – Contract/Interim
Medical Device Manufacturer
A well known, market leading manufacturer of medical devices is currently looking to hire additional resource to their Regulatory team to help prepare for a launch of a new line of Class 2b & Class 3 medical devices.
- Help define regulatory road map for successful submissions and regulatory approval
- Take ownership of preparing the technical file and other technical documentation ready for submission
- Help shape the Regulatory Affairs standard operating procedures to improve effectiveness of internal process
- Work closely with the senior leadership team to ensure they are aware of current and upcoming regulatory challenges
- Coordinate the regulatory team, carrying out some training to up-skill team
- At least 5 years’ experience in a regulatory affairs leadership role with a medical device manufacturer
- Ideally will have worked as a consultant/contractor before
- Will be comfortable with and experienced in working directly with senior leadership in a global Medical Device business
- Subject matter expert on regulatory submissions for CE Mark approval and FDA 510(k)/PMA
If you speak fluent German and are able to work from home and start as soon as possible, please apply and get in touch!
Send your CV or call for a discussion about the role on +44203 854 9412
Xplore is a specialist Regulatory Affairs recruitment agency.
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