Regulatory Affairs Specialist

We are currently looking for a Regulatory Affairs Specialist to join a leading Medical Device company based in the Cambridgeshire area.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Affairs Specialist will be varied however the key duties and responsibilities are as follows:

1. Make sure all the technical medical device files and the QMS is up to date to ensure compliance with the current regulation.

2. Provide regulatory documentation that supports all regulatory submissions for new and existing products.

3. Responsible for the review and approval of product labelling and support of post market surveillance.

4. Make sure you comply with cGMP and the continuous improvement of the QMS.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Regulatory Affairs Specialist we are looking to identify the following on your profile and past history:

1. Relevant degree in a life science background.

2. Proven industry experience in Regulatory Affairs.

3. A working knowledge and practical experience with IVD Medical Devices.

Key Words: RA, Regulatory Affairs, IVD, Class 2, QMS, GMP

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.