CK Group are recruiting for a Senior Regulatory Affairs Associate to join a global healthcare provider to hospitals, clinics and homes, on a remote basis or based at their site in Newbury, initially on a contract for 12 months.
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Per Hour £33.03 PAYE / £43.87 Umbrella
Our client is one of the worlds leading healthcare providers and has been highly innovative in providing healthcare solutions to unmet medical needs through scientific advancement as well as strategic acquisitions and partnerships. They work at the critical intersection where innovations that save and sustain lives meet the physicians, nurses and pharmacists who make it happen. Our client is committed to improving outcomes for patients, and helping their partners meet the evolving challenges and opportunities in healthcare around the world.
This role can be worked either remotely or on site in Newbury which is our clients headquarters with several different functions.
As a PAYE employee you would be entitled to:
Regulatory Affairs Associate Role:
Support the development/alignment of regulatory policies and strategies
Working with cross-functional groups to ensure the development of regulatory strategies for the CE and UKCA marking of new Medical Devices
Participate in regional Industry Association meetings
Interpret existing, pending and proposed regulations/guidance documents regarding MDD, MDR and UKCA
Supports the Legal Manufacturer in its fulfilment of its regulatory responsibilities under the MDD, MDR and UKCA
Degree in engineering or life sciences or similar
Proven experience preferably in Regulatory Affairs, Quality Assurance R&D or System, Standard Compliance testing
Good knowledge of CE marking of medical devices
Ability to liaise with the different functions involved in the elaboration of CE files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics
Ability to interpret European and UK regulations and guidelines and all technical product information in order to assure that regulatory requirements are met
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54472 in all correspondence
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