Post-Market Surveillance (Complaints) Specialist

the companyis 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.Our systems are used in over 3,000 clinics worldwide, including in 29 of the top 30 Best Hospitals for Cancer (source: US News and World Report 2026 rankings).The company is recognized as one of Britain’s fastest-growing private tech companies, as featured in the2025Sunday Times 100 Techlist. the company is also a recipient of the 2026 King’s Award for Enterprise, our fifth in 10 years. It is the UK’s most prestigious accolade for business excellence.Company videoWith around 400+ employees globally and offices in the UK, Poland, and the USA, the company 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.the company is a company with strong values, a clear mission, and a bright future. It is an exciting and rewarding organization in which to work.

About the role

The Post-Market Surveillance (Complaints) team is backfilling a position after a successful career development. The primary role of the successful applicant will be investigating support tickets, with root-cause analysis as the goal, and regulatory report writing as the end result. It suits someone with a history of investigation, an enquiring mind, and a desire to expand their knowledge within the non-clinical side of Surface Guided Radiation Therapy.

Key Responsibilities

• Assist in the review and classification of complaints against applicable regulations and company procedures to determine reportability.
• Under supervision, work with internal and external stakeholders to investigate complaints, determine the root cause and close or expand for further action as appropriate.
• Liaise with the Product Risk Management Team and other internal teams to complete initial risk assessments.
• Assist in supporting internal and external audits by the company’s notified body and other third parties.
• Work collaboratively with other teams within the Quality & Regulatory Compliance department and other areas, particularly Production, R&D and Service.
• Once trained, act as an internal auditor to ISO 13485, MDSAP and the EU MDR.
• Other duties as may be reasonably required.
• This role requires occasional UK and international travel.

Essential Skills & Experience

• Strong administration skills and attention to detail.
• Analytical and problem-solving skills.
• Ability to work independently and collaboratively, and ability to prioritise and plan tasks.
• Competent in Microsoft Office products.
• Fluent in written and spoken English

Desirable Skills & Experience

• Advanced MS Excel skills (e.g. VLOOKUP, Pivot Table analysis).
• Demonstrates understanding of navigating medical device regulations and regulatory guidance for regulatory submissions in MDSAP markets and/or the EU.
• Qualified internal auditor with experience of performing internal and/or supplier audits to ISO 13485, MDSAP requirements, the EU MDR and/or ISO 9001.
• 2 years’ experience with Trend Analysis.

the company is an Equal Opportunity / Aff…

#J-18808-Ljbffr