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Regulatory Affairs Manager at NES Fircroft

Regulatory Affairs Manager

NES Fircroft Gloucestershire, Gloucestershire Full-Time
£60 - £70 / hour
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Regulatory Affairs Manager
Medical Devices
South West
6 Month Contract
Ltd, Outside IR35
Remote with occasional site visits

NES are currently supporting a Medical Device business in their search for an interim RA Manager for a 6-month period. This could go on longer depending on project timeline and other factors.

Start date of approx. 19th October so please apply early for a call back and to be submitted.

The role:

Develop and implement regulatory strategies that ensure introduction of products or post market change management activities into global markets.
Coordinate Regulatory submissions
Technical file remediation as necessary
Post-market surveillance activities as required
Be the point of contact for regulatory agencies, notified bodies etc. 
You:

Educated to degree level or equivalent preferably in a scientific of engineering discipline
Experienced in regulatory submissions for IVD and/or medical devices.
Experience of working within the requirements of ISO 13485, the MDD / MDR and/or IVDD
5 years+ Medical Devices RA experience
Comfortable to hit the ground running in an autonomous contract role

Established in 1978, NES Global Talent provides a complete range of contract and permanent talent solutions to the Oil and Gas, Power, Construction and Infrastructure, Life Sciences, Manufacturing and IT sectors worldwide. With more than 40 offices in 28 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. Offering far more than a traditional recruitment service, we fully support our contractors while they are on assignment with everything from securing visas and work permits, to providing market leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients
 

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Job ID: 212501660