Post-Market Surveillance (Complaints) Specialist

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.

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.