Regulatory Affairs Specialist– 12 Fixed-term contract (with potential to go permanent) About the company Vision RT is a rapidly expanding MedTech company at the forefront of transforming radiation therapy. We are the inventors of Surface Guided Radiation Therapy (SGRT), which harnesses advanced 3D camera systems and sophisticated AI, Computer Vision, and Machine Learning software. Our mission is to enhance the safety, precision, and comfort of radiation therapy for patients. Notably, our innovative solutions are deployed across all 15 of the prestigious "Best Hospitals for Cancer," as recognized by US News & World Report Company video With around 300 employees globally, and offices in the UK, Poland & US, we operate autonomously as part of the Danish company Demant A/S, one of the largest healthcare companies in the world. 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 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 a similar field. Experience of internal and/or supplier audits