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 £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 (SaMD) to qualify for this position, as well as an essential requirement of ISO 13485 and DCB0129.
• 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 (SaMD)
• 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 & 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 regulatory and technical documentation and complete the required regulatory submissions
• Pragmatism and responsibility to drive activities
• 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
• Excellent verbal and written English and have reporting and presentation skills
• Clinical background with a current active registration
• Evident understanding of the MHRA (UK governing body) and the way that the Healthcare works in the NHS
• 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
• Life/health sciences-based undergraduate degree
• Ability to work in Customer facing situations with great communication skills
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
• Responsibility for preparation and submissions of regulatory applications and registrations
• Point of contact for competent authorities
• Create, modify, and maintain device Technical Files
• Maintain technical files according to requirements of current regulations and legislation
• Final regulatory approval of software validation reports prior to their release
• Regulatory subject matter expertise to support business activities
• Manage and address any audit device technical file non-conformities
• 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
• Maintain a knowledge of the changing regulatory standards and implement the changes necessary
• Deliver the supporting documentation required for sales frameworks and tender responses
• Manage and support the internal and external regulatory resource
• Working with ISO Compliance Manager to fulfil an audit schedule for medical device compliance
• 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