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Regulatory Affairs Specialist

4 months ago

Cambridgeshire, United Kingdom Hyper Recruitment Solutions Ltd Full time

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:
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