Regulatory Specialist and Senior Specialist - Manchester, United Kingdom - GxPeople Global

Description

GXPeople have partnered with a Medical Device Manufacturer in their search for a RA Specialist or a Senior RA Specialist to join the team at their Manchester headquarters.

In the position you will be responsible for ensuring that the company aligned with all its compliance obligations in the UK, EU and US and will work alongside QA and wider teams to prepare and submit regulatory documentation in relation to product changes, new products or reportable events.

To be successful in this role you will have 3-4 years of working in a Regulatory capacity in a Medical Device Environment.

Along with Benefits there is a yearly bonus on offer.
Monitoring & Maintenance of regulatory standards & Directives relevant to their products for both European and US geographies
Maintaining and updating Medical Devices files and Design History Files
Reporting to regulatory authorities (UK, EU and US) as required
Working with R&D and quality team on MDR and FDA submissions for new products