Medical Device Complaint Manager
4 weken geleden
Vicentra is a global leader in the medical device industry, dedicated to designing innovative products that empower people with diabetes to manage their condition. With a strong presence in Europe and a growing international footprint, Vicentra is committed to delivering best-in-class solutions that improve the lives of millions.
Salary
We offer a competitive salary of €75,000 per annum, plus an additional 8% holiday allowance, making a total annual remuneration package of approximately €81,500. This compensation reflects our commitment to attracting and retaining top talent in the industry.
Job Description
The Complaint Handling Manager plays a critical role in ensuring compliance with regulatory requirements and internal processes. Reporting directly to the management team, this position will oversee all aspects of complaint handling, working closely with Customer Care and Commercial teams, as well as distributors. Key responsibilities include:
- Managing/leading the team responsible for triage, investigation, and reporting of product complaints;
- Overseeing and reviewing investigation findings to ensure appropriate risk classification and compliance with regulatory requirements;
- Analyzing data and developing recommendations based on investigation findings;
- Performing trend analysis to detect signals and provide proactive solutions;
- Maintaining and monitoring systems to ensure effective complaint handling;
- Tracking team metrics to achieve performance targets;
- Continuously improving complaint handling processes through collaboration with internal stakeholders (R&D, Operations, Customer Care);
Required Skills and Qualifications
To succeed in this role, you will need:
- A degree in a technical or scientific field, or equivalent experience;
- A minimum of 5 years' experience in complaint handling within the medical device industry;
- Knowledge of global Medical Device Regulations, particularly EU MDR and FDA, in relation to complaint handling and adverse events;
- Working knowledge of medical device regulations, requirements, and standards, including 21 CFR 820, ISO13485, and 2017/745;
- Effective verbal communication and excellent technical writing skills;
- Proven ability to organize, prioritize, and follow through on multiple tasks with minimal supervision;
Benefits
Vicentra offers a comprehensive benefits package, including:
- 25 days of holiday per year, plus flexible working hours and hybrid working options;
- A partially company-subsidized pension scheme;
- Subsidized gym membership and bike-to-work scheme;
- Ongoing training and development opportunities to enhance your skills and career growth;
Others
We are an equal opportunities employer, welcoming applications from all suitably qualified individuals regardless of their background, race, sex, disability, religion, sexual orientation, or age. In order to work for Vicentra, candidates must have the right to work in the Netherlands.
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