Regulatory Affairs Specialist

Posted 26 October by Next Phase Recruitment
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A great opportunity to join an innovating global healthcare company specialising in orthopaedic medical equipment. They are well established being around since 1984 and are currently going through a phase of expansion. They urgently need a Regulatory Affairs Specialist to aid in the development strategy and approval of new medical devices.

This role will be rewarding allowing the possibility of line management and a competitive salary. The role also presents a flexible home-working arrangement being able to work from home for the majority of the week. In addition to this, a flexible hours-working arrangement where you can flex a certain number of hours around the core working hours within the company.

RESPONSIBILITIES OF THE ROLE:

The Key Accountabilities of the RA Specialist include the following:
  • Creating, maintaining, and managing Technical Files for UK and international markets including Europe (MDR), Canada and the USA.
  • Management of the change control system, including design change, process change etc.
  • Obtain and maintain UKCA approval, CE certification and FDA clearance (510(k))
  • Collate and submit Technical Files to the Notified Body
  • Assist in the creation and maintenance of design history files and risk management files
  • Creating and maintaining Summary Technical Documentation files and General Safety and Performance Requirement Checklists
  • Act as regulatory project leader for new product introduction
QUALIFICATIONS AND EXPERIENCE:
  • A bachelor’s degree in life sciences or engineering, or equivalent
  • Minimum of four years’ experience in Medical Devices
  • Knowledge of regulatory submissions and technical file creation/maintenance


Reference: 44488611

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