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 Senior RA Specialist will report to the Regulatory Affairs Manager.
This position offers remote flexibility based on experience. Candidates who meet all skill requirements may work remotely, with an expectation of 2-3 days per month at our London or Basingstoke office, particularly during the early stages of the contract.
For candidates who may need to develop certain skills, we offer a hybrid work model, requiring regular in-office collaboration in London or Basingstoke to support learning and development.
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.
* Plan and perform clinical evaluations of the company’s medical devices.
* Maintain Technical Documentation to ensure that the company’s compliance with applicable standards, regulations and guidance is documented.
* Act as a senior member of the Quality & Regulatory Compliance team, mentoring and supporting peers and junior colleagues.
* Act as an auditor of internal functions and external suppliers.
* Act as a Subject Matter Expert for internal and external audits.
* Other duties in support of the company’s quality policy and objectives.
* Occasional UK and international travel.
Essential Skills & Experience
* At least 5 years’ experience in a medical device company in a Regulatory Affairs role.
* 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.
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