 Regulatory Affairs Manager - Yorkshire
Location: York, England
Regulatory Affairs Manager – Medical Devices - York
A global organisation is currently recruiting for a Regulatory Affairs Manager to join there rapidly expanding organisation. This Prestigious organisation provides a range of services and products. This fantastic organisation complies with high Quality standards that continue growth and development within the company.
They are looking for someone to plan and deliver their work on time, providing solutions to problems encountered. As a Regulatory Affairs Manager you will provide leadership in the introduction and the development of new and existing markets globally, ensure all regulatory and quality systems are in place are maintained and established along with accurate decisions made within scope of the role.
You must have a minimum of 8 years’ experience within the area of Medical Devices and proven ability to work a part of a team, someone who has a working knowledge of Medical Device 13485 You must have experience in Regulatory Affairs and documentation techniques, managerial skill, ideally someone who has a good working knowledge of Medical Device Regulations (FDA GMPs/510K applications, and ISO 13485. As a Regulatory Affairs Manager you will have experience with regulatory agency interactions related to PMA, 510 (k), experience in a manufacturing, along with adhering to safety and compliance with regulatory requirement.
As a Regulatory Affairs Manager you will have the responsibility of managing the development and availability of the correct technical files and data supporting each product, internal audits, QC Specifications, control of quality related documents, project manage the necessary technical activities providing direction and leadership, ensuring that company objectives and regulatory requirements are met. Identify new, or changes to existing, processes and systems to improve effectively and efficiency of the Quality system in accordance with the requirements necessary Along with the ability to develop strong working relationships.
The working environment and quality of work within the business are of the highest order and the successful individual can expect to be well rewarded both with their career development. Subsequently they are looking for someone to come in and be a good communicator and a great influencer to the business proving solution. This is a new role that is growing rapidly; this position would potentially suit a candidate looking for a new challenge along with demonstrating their abilities.
If you want to be a part of this exciting opportunity, Please contact Ekta Multani, Medical Devices Recruitment consultant at Paramount Recruitment on 0121 616 3474.
Key Words: Regulatory Affairs Manager, Technical Manager, Quality Engineer, Quality Advisor, Quality Systems, Medical Devices, ISO 13485, Quality Systems, Surrey, CAPA, Medical Device Directive, QMS, 21 CFR part 820, Quality Control, Management, Six Sigma, LEAN, GMP, Quality Engineering Manager, ISO 9001, MHRA, Compliance, Audits
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