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Medical Device Regulatory Specialist
Location:
Milton Keynes
Description:
Position: Medical Device Regulatory Specialist Suitable for: Regulatory Affairs Specialist with strong experience of ISO 13485 and MDD and MDR Location: Hybrid, ideally Surrey based, with the expectation to travel to Milton Keynes and Surrey sites if required (approx. once a month) + client travel as and when required Salary: Up to GBP 50k + bens Our client is a software development company that provides solutions to the healthcare IT market and is seeking a talented and experienced Medical Device Regulatory Specialist dedicated to delivering telehealth services within the digital healthcare market. The Medical Device Regulatory Specialist will directly contribute to this area of medical services, influencing the improved effectiveness of community: based care using devices. Therefore, the Medical Device Regulatory Specialist will require experience in the context of Software as a Medical Device (Sa MD) to qualify for this position, as well as an essential requirement of ISO 13485 and DCB0129. Essential: - Min 3 years' experience as Medical Device Regulatory Specialist, Regulatory Affairs Specialist with medical device experience- Good working experience of Software as a Medical Device (Sa MD)- Technical background within medical devices with an in: depth understanding of the regulatory function, with good knowledge of related quality, engineering, clinical, safety, and post: market functions. - Strong understanding of Medical Device Directive / Medical Device Regulation transition process. - Up: to: date working knowledge of: : MDD and MDR (Class 1 and 11a devices) : BS EN ISO 13485, 14971, 14155, 27001 : BS EN IEC 60601 : BS EN 62304 : NHS DCB0129 / DCB0160 : UK General Data Protection Regulation - Good working knowledge of EN 62304, having maintained electronic and software devices technical files. - Experience in the production and maintenance of documentation supporting NHS DCB0129/0160- Willingness and ability to write and update. Visit ListedBuy for more information.
Posted:
March 21 on ListedBuy
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More About this Listing: Medical Device Regulatory Specialist
Medical Device Regulatory Specialist is a Human Resource Regulatory Affairs Specialist Job located in United States. Find other listings like Medical Device Regulatory Specialist by searching Oodle for Human Resource Regulatory Affairs Specialist Jobs.
Medical Device Regulatory Specialist is a Human Resource Regulatory Affairs Specialist Job located in United States. Find other listings like Medical Device Regulatory Specialist by searching Oodle for Human Resource Regulatory Affairs Specialist Jobs.