Regulatory Affairs Specialist – Medical Devices - 12 month Fixed Term Contract (with potential to go permanent)

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 role
The position sits within the Quality and Regulatory team. You will play a pivotal role in obtaining and maintaining marketing approvals for Vision RT products globally, implementing the firm's regulatory strategy and providing regulatory expertise to support business development. The RA Specialist will report to the Regulatory Affairs Manager.

Key Responsibilities Will Include:

• Lead on Vision RT’s product submissions to competent authorities in line with the company’s product development roadmap and market expansion strategy, with a general focus on EU and US but also including RoW.
• Act as an extended member of the R&D team to develop and implement regulatory plans for new and changed products.
• Monitor and analyse changes in the regulatory environment and implementing strategies for meeting new and changed requirements to ensure business continuity in target markets.
• Liaise with internal and external stakeholders, providing training and support to ensure that regulatory requirements are met.
• Prepare and submit pre- and post-market reports to regulators and local representatives.
• Maintain Technical Documentation to ensure that the company’s compliance with applicable standards, regulations and guidance is documented.
• Act as an auditor of internal functions and external suppliers.
• Other duties in support of the company’s quality policy and objectives.
• Occasional UK and international travel.

Essential Skills & Experience

• Regulatory Affairs experience in a medical device company.
• ISO 13485 or MDSAP
• Experience of CE marking (MDR) medical devices and/or preparing US 510(k) (FDA) submissions.
• Competent in Microsoft Word, Excel, PowerPoint, Outlook and general computer usage.
• Fluent in written and spoken English.

Desirable Skills & Experience

• A degree/qualification in health sciences, medical engineering, law or similar field.
• Experience of internal and/or supplier audits to ISO 13485, MDSAP and/or ISO 9001.

Vision RT is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment and development without regard to race, colour, religion, sexual orientation, gender, national origin, disability, or protected veteran status.