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
- 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
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