Regulatory Affairs Specialist - Medical Devices - Oxford
A global organisation is currently recruiting for a Regulatory Affairs Specialist to enjoy there rapidly expanding organisation. This International organisation provides a range of services and products for customers globally having over 5000 employees worldwide.
Key responsibilities of the role will be to maintain the process of Regulatory documentation to MDD (Medical Devices Directive) standards. You will be also providing Quality Management Systems, Audit processes, review actions and stages for its timely completion, preparation and maintenance of Technical Files and documentation you will be a responsible will also ensure that all preparation of annual product reviews and generate documents as necessary for management reviewed.
An ideal candidate must have experience in Regulatory Affairs and documentation techniques, good working knowledge of Medical Devices/ CAPA Processes that would be advantage and ISO 13485 regulations. You should have excellent interpersonal skills, be able to work under pressure and on your own initiative. You must have within the Medical Devices or a regulatory industry. You will also be expected to have a good working knowledge of MDD and Medical Devices Regulatory policies.
If successful, you will be rewarded with a generous salary, excellent benefits package, including healthcare and a company pension scheme.
If you have the drive and enthusiasm to be a part of this exciting opportunity, please contact Ekta Multani, Recruitment Consultant at Paramount Recruitment 0121 616 3474 or email ekta.multani@paramountrecruitment.co.uk.
Keywords: Regulatory Affairs, Medical Devices, Clinical Studies, Design Dossiers, IFUs, Management, OXFORD, MDD, Medical Device Directive, ISO 13485, FDA, 510K
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