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:
Requirements for this role:
- 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.
- 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!