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Regulatory Specialist, Medical Devices

Oxfordshire   •  Permanent, Full time


Amy Lloyd at CK Group is recruiting for a Regulatory Specialist for Medical Devices, working for a fast-paced small bio-tech company.

Sitting on the Project Team, you will work across a wide variety of projects delivering against agreed regulatory strategies. My client is looking for an experienced regulatory affairs specialist to assist with the development and delivery of regulatory documentation for medical devices.

Responsibilities:
- Working alongside the quality and technical leads writing regulatory and quality documentation for submission.
- Prepare documentation for CE marking dossier.
- Prepare for and attend meetings with Notified Bodies.
- Co-ordinate external contractors and internal Medical Writers/technical experts assigned to the project.
- Co-ordinate all device related technical questions i.e. biocompatibility, risk management, toxicology, usability, sterilization etc.

Essential Requirements:
- Bachelor’s degree in a scientific or technical subject.
- 5 years + experience in EU regulatory standards with a proven track record of writing and submitting device regulatory documentation to appropriate ISO and FDA standards.
- Knowledge of pre-market and post-marketing regulatory requirements and processes for medical devices in EU, as well as knowledge of upcoming changes under MDR.
- Excellent written and verbal communication skills.
- Ability to build strong relationships and work collaboratively both with internal team members and external CRO partners.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46767 in all correspondence.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Amy Lloyd
  • Phone: 01438 743047
  • Reference: 46767
  • Updated: 30th October 2019
  • Expires: 27th November 2019

CK Group

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