Senior Medical Devices Regulatory Affairs Manager

Location: Oxford  |  Oxfordshire  |  England
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHSMDRAM
Salary: £45000 - £65000
Job Status: Permanent / Full Time

Currently searching for a high quality, innovative and product driven EU Senior Medical Devices Regulatory Affairs Manager in Oxford to meet with EU Regulatory Affairs requirements for a range of medical devices. Suitable candidates must have.

5 years of medical device, diagnostic or related industry experience in Regulatory Affairs ideally in sterile implantable

Knowledge and understanding of, EU and Medical Device regulations

Demonstrated success in preparing medical device pre-marketing applications and CE mark technical files, ideally at least class 2b devices.

Responsibilities

  • Prepares EU RA strategies. Plans, prepares and co-ordinates the development of pre-market applications and related submissions to Notified Bodies and other regulatory agencies.
  • Provides guidance to cross functional product development teams regarding conformance with medical device regulations, standards and guidance documents, including data required to substantiate product claims and content of labelling, advertising and promotional materials. Interacts with regulatory authorities as required.

If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.