Regulatory Affairs Specialist
2 weeks ago
A growing Biotech company in Cambridgeshire is looking for a Regulatory Affairs Specialist, to support the Regulatory team.
**As a Regulatory Affairs Specialist, you will**:
- Compile and review medical device files for the company's products;
- Produce documentation supporting regulatory submission to comply with regulatory authorities;
- Work with the team to support regulatory submission to the noted authorities;
- Work within GMP and help development of QMS documents;
- Review product development and maintain regulatory procedures.
**Requirements for this role**:
- Degree in relevant a Life Science discipline; with understanding of the biotech industry;
- Regulatory Experience working to IVDR or medical device standards;
- Desirable if you have knowledge with domestic and global regulations.
Hybrid working is available. Need to be on site 2-3 days a week
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