Compliance Engineer

Vision RT Ltd; Basingstoke; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading MedTech company in the UK is seeking a Compliance Engineer to compile key requirements and safety documentation for regulatory clearances. The ideal candidate will have a degree in a science or engineering-based subject and over 3 years of experience in regulatory compliance for medical devices. Responsibilities include assuring product compliance, managing testing activities, and updating quality management systems. The role offers full-time employment and requires occasional travel. Exceptional attention to detail and teamwork skills are essential.

Qualifications

• More than 3 years’ experience in regulatory compliance for medical devices.
• Experience in risk management and quality management is preferable.

Responsibilities

• Assuring products meet current regulatory requirements and standards.
• Establishing product requirements and associated testing approaches.
• Collaborating with teams to ensure safety deliverables for product releases.
• Managing third-party testing activities according to safety standards.
• Updating the QMS to comply with regulatory requirements.
• Conducting Design Safety Risk Management activities.

Skills

Product requirements relating to safety standards (i.e. ISO, IEC, etc)

Testing methods

Excellent attention to detail

Excellent prioritising, organisational, and interpersonal skills

Fluent in English

Computer Proficiency with MS Office

Strong organisational skills

Ability to work in a fast-paced environment

Critical thinking and problem-solving skills

Detail-oriented and adaptable attitude

Education

Degree in science or engineering-based subject

Job description

Join to apply for the Compliance Engineer role at Vision RT Ltd

About the Company

Vision RT is a fast-growing MedTech company transforming radiation therapy for cancer patients by helping make it more accurate, effective, and comfortable. The company is the inventor of, and a market leader in, Surface Guided Radiation Therapy (SGRT). This technology uses advanced 3D cameras to track surface data, providing enhanced guidance across every step of the radiotherapy workflow. Vision RT’s SGRT solutions are in 24 out of the 25 “Best Hospitals for Cancer,” as tracked by US News & World Report. The company is recognised as one of Britain’s fastest-growing private tech companies, as featured in the 2025 Sunday Times 100 Tech list. Vision RT is also a recipient of the 2024 King’s Award for Enterprise, the UK’s most prestigious accolade for business excellence. With around 300 employees globally and offices in the UK, Poland, and 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. Employees benefit from the security and reach of being part of a large global enterprise, combined with the agility and innovation of a startup. Vision RT is a company with strong values, a clear mission, and a bright future. It is an exciting and rewarding organisation in which to work.

About the Role

Working 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.

Responsibilities

• Assuring 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.

Qualifications

• Degree 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.

Required Skills

• Product requirements relating to safety standards (i.e. ISO, IEC, etc).
• Testing methods.
• Documents such as Initial Safety Design Reviews.
• Excellent 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.

Preferred Skills

• Recognised 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.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Engineering and Quality Assurance

Industries

Medical Equipment Manufacturing and Computers and Electronics Manufacturing

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