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

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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. Were one of Britains fastest-growing private tech companies, as recently recognised by the 2025 Sunday Times 100 Tech list. Were also the proud winners of a 2024 Kings Award for Enterprise, the UKs 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 worlds 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. Its an exciting and rewarding place to work.

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.

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• Lead on Vision RTs 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 companys 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 companys quality policy and objectives.
  
• Occasional UK and international travel.
  

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• 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.
  

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• 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.