Post-Market Surveillance (Complaints) Specialist
Vision RT Ltd.
Summary
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.
Job description
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 escalate 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 Vision RT'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.
Requirements
- 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
- 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.
Company overview
Vision RT Ltd. is a pioneering medical technology company that invented Surface Guided Radiation Therapy (SGRT), revolutionizing cancer treatment through advanced computer vision and AI-powered solutions. Founded in 2001 and headquartered in London, England, the company specializes in developing innovative radiation therapy systems that enhance the accuracy, safety, and comfort of radiotherapy treatments. Vision RT's flagship product, AlignRT, is the market-leading SGRT system that uses 3D stereo cameras and real-time monitoring to ensure radiation is delivered only when patients are correctly positioned, achieving sub-millimetric accuracy across all skin tones and treatment angles. The company's comprehensive product portfolio includes SimRT for CT simulation, MapRT for treatment planning, AlignRT for treatment delivery, and DoseRT for real-time dose visualization. With over 2,600 systems in active clinical use worldwide, including installations in 24 of the top 25 cancer centers in the United States, Vision RT has established itself as a global leader in radiation therapy technology. The company's solutions eliminate the need for radiation therapy tattoos and restrictive immobilization devices, significantly improving patient comfort while maintaining exceptional treatment precision. Vision RT continues to innovate with recent developments including Beam Guide for real-time radiation field visualization, Auto ROI for automated region-of-interest definition, and advanced patient monitoring capabilities that are transforming cancer care globally.