Senior Regulatory Affairs Specialist

GxPeople Global
Manchester
GBP 60,000 - 80,000
Job description

Job 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.

You will be part of innovative company who are at the forefront of their therapeutic area and the first ones to have developed these types of devices.

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. You will need to have experience in US, EU & UK regulations.

Salary on offer is competitive and dependant on experience. Along with Benefits there is a yearly bonus on offer.

Responsibilities:

  • 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
  • Working with wider teams to implement engineering changes to identify and manage reportable changes
  • Reporting to regulatory authorities (UK, EU and US) as required
  • Working with the QA team to support PMS and PSUR
  • Preparation of 510(k) and NB submissions for new and existing products
  • Working with R&D and quality team on MDR and FDA submissions for new products
  • Contribution to the development of new QMS procedures

Essential Experience:

A familiarity with operating to IS013485 and 21 CFR Part 820 compliant processes & procedures

Experience of preparing and submitting FDA 510(k) and EU MDR applications

Degree qualified or qualified by experience

If this role sounds interesting please apply to the advert or get in touch with me for more information.

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