Medical device regulatory specialist

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 GBP50k + 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 (SaMD) to qualify for this position, as well as an essential requirement of ISO 13485 and DCB0129. Essential: bull; Min 3 years rsquo; experience as Medical Device Regulatory Specialist, Regulatory Affairs Specialist with medical device experience bull; Good working experience of Software as a Medical Device (SaMD) bull; 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. bull; Strong understanding of Medical Device Directive / Medical Device Regulation transition process. bull; Up-to-date working knowledge of: * MDD and MDR (Class 1 11a devices) * BS EN ISO 13485, 14971, 14155, 27001 * BS EN IEC 60601 * BS EN 62304 * NHS DCB0129 / DCB0160 * UK General Data Protection Regulation bull; Good working knowledge of EN 62304, having maintained electronic and software devices technical files. bull; Experience in the production and maintenance of documentation supporting NHS DCB0129/0160 bull; Willingness and ability to write and update regulatory and technical documentation and complete the required regulatory submissions bull; Pragmatism and responsibility to drive activities bull; Work effectively, both independently and as part of a team and develop, maintain and work to defined project plans and have a structured and methodical approach bull; Excellent verbal and written English and have reporting and presentation skills Desirable: bull; Clinical background with a current active registration bull; Evident understanding of the MHRA (UK governing body) and the way that the Healthcare works in the NHS bull; Experience working with different teams (such as developers, testers, account managers, marketing and auditing departments) in a Medical Device compliance capacity within a software product environment bull; Life/health sciences-based undergraduate degree bull; Ability to work in Customer facing situations with great communication skills The Role: The focus of the Medical Device Regulatory Specialist is the production of medical device technical in compliance with the Medical Device Regulation and ISO 13485 (Medical Devices). Some input will also be required to support ongoing compliance with other ISO standards bull; Responsibility for preparation and submissions of regulatory applications and registrations bull; Point of contact for competent authorities bull; Create, modify, and maintain device Technical Files bull; Maintain technical files according to requirements of current regulations and legislation bull; Final regulatory approval of software validation reports prior to their release bull; Regulatory subject matter expertise to support business activities bull; Manage and address any audit device technical file non-conformities bull; Ensure regular collection of evidence for the annual clinical evaluation and post market surveillance reports and create the reports, notifying the relevant authorities to any abnormal trends bull; Maintain a knowledge of the changing regulatory standards and implement the changes necessary bull; Deliver the supporting documentation required for sales frameworks and tender responses bull; Manage and support the internal and external regulatory resource bull; Working with ISO Compliance Manager to fulfil an audit schedule for medical device compliance bull; Maintain security, integrity, and the confidentiality of data Full job description will be sent to you after initial call and if the role is of interest to you. To apply: Please follow the online application process and upload your CV, in Word format. Please note: You must be eligible to work in the UK for your application to be considered (sorry, our client is unable to offer sponsorship). Due to large numbers of applications, unfortunately we cannot provide detailed feedback to everyone, however, if you wish to find out how your application is progressing please call or e-mail the office and someone will help you / get back to you