Regulatory Affairs Manager - Remediation, Oxford

Regulatory Affairs Manager Medical Devices Remediation Project 12 Month Contract £65-75 per hour Home / Flexible Working Outside IR35 NES are currently partnering with a large Medical Device business going through large scale remediation projects across their product lines for MDR as well as looking to complete on multiple product registrations and submissions in the US & APAC regions. Overview: To manage the business's regulatory affairs strategy relating to MDR transition and the associated remediation work involved. You will be required to communicate at all levels within the business and with external partners. The business is also looking to register products in the US & APAC regions so previous experience to support on these projects will be beneficial, particularly with class 2 & 3 devices. You will: Create, manage, and maintain Tech Files Overseeing CE Marking Leading the transition from MDD to MDR for the business Complete product registrations and submissions in US and APAC regions Lead the development of the company?s regulatory plan, incorporating strategies for the product range in accordance with global requirements. Support product risk management activities Experience: Knowledge & experience of ISO 13485 and MDR requirements Demonstrate strong project management skills. Excellent communication skills Working with class 2 & 3 devices would be an advantage 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