Post-Market Surveillance, Complaints Specialist

Vision RT Ltd

. Investigate support tickets with root-cause analysis as the goal and regulatory report writing as the end result .

Posted 9/29/2026full-timeBasingstoke • United KingdomMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory report writing, root-cause analysis, and internal auditing for ISO 13485, MDSAP, and EU MDR compliance. Proficient in collaborating with cross-functional teams and managing support tickets while ensuring adherence to medical device regulations.

Highest-signal resume keywords

Regulatory Report WritingRoot-Cause AnalysisInternal Auditing to ISO 13485Trend AnalysisMedical Device Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Report WritingRoot-Cause AnalysisTrend AnalysisAdvanced MS ExcelISO 13485MDSAPEU MDRInternal AuditingData AnalysisComplaint Classification

Soft Skills

Attention to DetailAnalytical SkillsProblem-Solving SkillsCollaborationTask Prioritization

Tools & Technologies

Microsoft OfficeMS Excel

Certifications & Qualifications

Qualified Internal Auditor

Industry Keywords

Medical Device RegulationsRegulatory ComplianceQuality Management SystemsRisk AssessmentInternal Audits

About the role

Key responsibilities & impact

Investigate support tickets with root-cause analysis as the goal and regulatory report writing as the end result
Assist in reviewing and classifying complaints against applicable regulations and company procedures to determine reportability
Work with internal and external stakeholders to investigate complaints, determine root cause, and close or escalate cases 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
Collaborate with Quality & Regulatory Compliance, Production, R&D, Service, and other teams
Once trained, act as an internal auditor to ISO 13485, MDSAP, and the EU MDR
Perform other reasonably required duties
Undertake occasional UK and international travel

Requirements

What you’ll need

Strong administration skills and attention to detail
Analytical and problem-solving skills
Ability to work independently and collaboratively
Ability to prioritise and plan tasks
Competent in Microsoft Office products
Fluent in written and spoken English
Advanced MS Excel skills, e.g. VLOOKUP and Pivot Table analysis (desirable)
Understanding of medical device regulations and regulatory guidance for submissions in MDSAP markets and/or the EU (desirable)
Qualified internal auditor with experience performing internal and/or supplier audits to ISO 13485, MDSAP requirements, the EU MDR and/or ISO 9001 (desirable)
2 years’ experience with Trend Analysis (desirable)

Benefits

Comp & perks

Permanent, full-time employment
Opportunity to work for a fast-growing MedTech company
Employees benefit from the security and reach of a large global enterprise combined with startup agility and innovation
Career development opportunities
Occasional UK and international travel