Regulatory Affairs Specialist for Medical Devices
2 weeks ago
**Job Description:**
We are seeking an experienced Regulatory Affairs Manager to join our team at X4 Life Sciences, a London-based start-up medical device company.
The successful candidate will assist with regulatory tasks, oversee technical files, work with Notified Bodies, and ensure EU compliance. Key responsibilities include:
- Developing and managing regulatory documents for medical devices and pharmaceuticals;
- Obtaining FDA and FDR approval for new products;
- Providing regulatory guidance and support to the team;
- Developing EU regulatory strategies for product launches;
- Managing project assignments and coordinating with internal teams;
- Liaising with government agencies to stay up-to-date on regulatory changes.
**Requirements:**
- More than 7 years' experience in regulatory affairs;
- Expert knowledge of MDR, ISO13485, and UK MDR regulations;
- Experience interacting with Notified/Approved Bodies;
- Ideally, experience in orthopedics or surgical devices.
**Estimated Salary:** £80,000 - £100,000 per annum, depending on experience.
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