Associate Complaints Officer
Role Overview
Join the Post-Market Surveillance (Complaints) team in a backfill role.
Investigate support tickets, identify root causes, and produce regulatory reports.
The role suits an investigative candidate interested in the non-clinical side of Surface Guided Radiation Therapy.
Key Skills for This Role
Full Job Posting
Role overview
Join the Post-Market Surveillance (Complaints) team in a backfill role.
Investigate support tickets, identify root causes, and produce regulatory reports.
The role suits an investigative candidate interested in the non-clinical side of Surface Guided Radiation Therapy.
Responsibilities
- Review and classify complaints under applicable regulations and company procedures to determine reportability.
- Investigate complaints with internal and external stakeholders, determine root causes, and close or escalate cases.
- Work with Product Risk Management and other teams on initial risk assessments.
- Support notified-body and third-party audits.
- Collaborate with Quality and Regulatory Compliance, Production, R&D, Service, and other teams.
- After training, act as an internal auditor for ISO 13485, MDSAP, and EU MDR.
- Travel occasionally in the UK and internationally.
Essential skills and experience
- Strong administration skills and attention to detail.
- Analytical and problem-solving skills.
- Ability to work independently and collaboratively, prioritize, and plan tasks.
- Competence in Microsoft Office products.
- Fluent written and spoken English.
Desirable skills and experience
- Advanced MS Excel skills, such as VLOOKUP and PivotTable analysis.
- Understanding of medical device regulations and regulatory guidance for submissions in MDSAP markets and/or the EU.
- Internal auditor qualification and experience auditing to ISO 13485, MDSAP, EU MDR and/or ISO 9001.
- Two years of trend analysis experience.
UK benefits
- Discretionary annual bonus scheme, subject to eligibility and company and individual performance.
- Pension contribution, life insurance, critical illness cover, gym contribution, private health insurance, and healthcare cash plan.
- 25 days of annual leave, sick pay, and an Employee Assistance Programme.
About Vision RT
Vision RT develops Surface Guided Radiation Therapy technology using 3D cameras to track surface data and guide radiotherapy workflows.
The company reports that its systems are used in more than 3,000 clinics worldwide and that it has around 400 employees globally.
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