Regulatory Affairs Specialist (18 months FTC)
Basingstoke, Hampshire
Finance & Ops – Quality Systems & Complaints /
Contract. Full-time /
Hybrid
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
The Regulatory Affairs Specialist will support global regulatory submissions and compliance activities for Vision RT’s medical device portfolio. This role ensures timely maintenance of regulatory approvals, contributes to post‑market surveillance activities, and supports audits and internal quality systems. It is an excellent opportunity for someone with foundational regulatory experience to deepen their expertise in a dynamic, innovative medical device company.
Key responsibilities will include:
- Author and compile Technical Documentation to support CE marking and global regulatory submissions.
- Liaise with local authorised representatives and competent authorities to facilitate regulatory reviews and approvals.
- Prepare departmental reports for internal stakeholders, including inputs for management review.
- Assist in planning and executing PMS, PMCF and Vigilance activities, including health hazard evaluations, clinical and post‑market reports required worldwide.
- Maintain databases and records relating to global regulatory clearances.
- Support internal and external audits conducted by Vision RT’s notified body and other third parties.
- Collaborate closely with colleagues across the Quality & Regulatory Compliance department and partner teams such as Production, Process Engineering and R&D.
- Act as an internal auditor to ISO 13485, MDSAP and the EU MDR.
- Perform additional duties as reasonably required.
- Undertake occasional UK and international travel.
Essential Skills & Experience
- Degree or equivalent qualification in Regulatory Affairs, Law, Engineering, or another relevant scientific discipline, or demonstrable equivalent work experience.
- Minimum of 2 years experience in medical device regulatory affairs or a similar role.
- Demonstrated understanding of medical device regulations and regulatory submission requirements for MDSAP markets and/or the EU.
- Qualified internal auditor with experience conducting internal and/or supplier audits to ISO 13485, MDSAP, EU MDR and/or ISO 9001.
- Strong administrative skills with exceptional attention to detail.
- Strong analytical and problem‑solving capability.
- Ability to work both independently and collaboratively, with effective task planning and prioritisation skills.
- Proficient in Microsoft Office applications.
- Fluent in written and spoken English.
Desirable Skills & Experience
- Experience working with Class IIb or Class III medical devices.
- Familiarity with U.S. FDA 510(k), FDA QMSR/21 CFR 820, or other global submission pathways.
- Knowledge of risk management (ISO 14971) or usability engineering (IEC 62366).
- Experience with clinical evaluation or post‑market surveillance documentation.
- Prior involvement in regulatory strategy for new product development.
- Experience using eQMS systems (e.g., Greenlight Guru).
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.
