Compliance Engineer

Vision RT is a rapidly growing MedTech which is transforming radiation therapy for cancer patients, helping to make it more accurate, effective and comfortable. We are the inventors of, and the market leaders in, Surface Guided Radiation Therapy (SGRT). This technology uses advanced 3D cameras to track surface data, for more guidance across every step of the radiotherapy workflow.Our SGRT solutions are used in 24 out of the 25 “Best Hospitals for Cancer,” as tracked by US News & World Report.We’re one of Britain’s fastest-growing private tech companies, as recently recognised by the 2025 Sunday Times 100 Tech list. We’re also the proud winners of a 2024 King’s Award for Enterprise, the UK’s most prestigious accolade for business excellence.Company video With around 300 employees globally, and offices in the UK, Poland & the USA, Vision RT operates independently as part of the Danish company William Demant Invest A/S - one of the world’s largest investors in healthcare companies. Vision RT staff members have the security and reach that comes with being part of a large global enterprise, combined with the freedom and agility of a startup.This is a company with strong values, a clear mission and a bright future. It’s an exciting and rewarding place to work.About the roleWorking closely with different teams throughout Vision RT, the Compliance Engineer will be responsible for compiling key requirements and safety documentation required for global regulatory clearances and approvals.As part of the Hardware Team, this role will involve close collaboration with Regulatory, Quality Software Development, Production and Service teams, as well as third parties.Key safety documentation includes top-level Design History File documentation required to demonstrate regulatory compliance with standards relating to Safety for all the products in the Vision RT portfolio.This role will be located in our Basingstoke office, and occasional travel to other offices or for supporting 3rd party testing will be required.Key responsibilities will includeAssuring that Vision’ RT products meet current regulatory requirements, standards and guidance using ‘State of the Art’ methods and techniques for Safety.Establishing product requirements and associated testing approaches required to meet regulatory standards.Working closely with development teams and the regulatory team to ensure safety deliverables are met for product releases.Assisting in planning and managing third-party testing activities for testing to (IEC 60601-1 and IEC 62368-1) General Safety and EN 60601-2 / EN 61000-4-2 (EMC) and related standards.Reviewing and updating the company QMS in relation to Safety to ensure they comply with existing and emergent regulatory requirements and guidance.Performing Design Safety Risk Management activities.Training and mentoring others to understand current regulatory requirements, standards and guidance.Must be willing and able to travel nationally (occasionally) or internationally (infrequently) as necessary.Must be able to work at least 3 days a week from the office.Essential Skills & ExperienceDegree in science / engineering-based subject or a higher-level technical qualification in an engineering subject and more than 3 years’ experience in regulatory compliance, risk management, quality management for medical devices or comparable experience in an equivalent role for non-medical devices.Product requirements relating to safety standards (i.e. ISO, IEC, etc)Testing methodsDocuments such as Initial Safety Design ReviewsExcellent attention to detail.Excellent prioritising, organisational, and interpersonal skills. Fluent in English, speaking and reading ability.Computer Proficiency with MS Office (Word/Excel/Access/Outlook).Strong organisational skills e.g. participating in meetings, setting/agreeing actions and driving them to closure, monitoring actions for effectiveness etc.Ability to work in a fast-paced environment with multiple tasks/projects.A critical thinker with good attention to detail and problem-solving skills as well as a demonstrable level of understanding of technical areas.Must have a detail-oriented attitude with a “can-do” and adaptable attitude and ability to work in a team environment as well as individually with minimal supervision.Willingness to accommodate a flexible working schedule that may involve evening and weekend working hours, depending on project requirements.Desirable Skills & ExperienceRecognised professional qualification in risk management or design safety.Any of the following: ISO 13485 (Quality), ISO 14971 (Risk Management), IEC 60601-1 & IEC 62368 (General Safety), EN 60601-2:2015 EN 61000-4-2 (EMC), IEC 60825-1, EN 62471 (Light sources), EN 62304 (Software) and EC 27001, UL 2900-1 & IEC 80000 Series (Cybersecurity)Experience in working with an international company across many cultures and time zones.