Manager Complaint Handling

Wat ga je doen?

The Complaint Handling Manager is responsible for all aspects of the complaint handling process and ensures compliance to the regulatory requirements that apply and internal processes. This role will work closely with the Customer Care and Commercial teams, including distributors to make improvements in the complaint and feedback process.

Main Responsibilities include but are not limited to:

Internal

• Manages/Leads the team that handles the triage, investigation, and reporting of product complaints.
• Oversees and reviews investigation findings to ensure the appropriate risk classification is assigned and ensures compliance with regulatory requirements.
• Analyses data and reviews recommendations and solutions based on the investigation findings.
• Performs data analysis on complaint trends to proactively detect signals and provide solutions.
• Maintains and monitors systems to ensure that all product complaints received are appropriately investigated and concluded per ViCentra’s complaint handling procedure.
• Track team metrics to ensure performance targets are achieved.
• Continuous improvements on the complaint handling process in cooperation with all internal stakeholders (R&D, Operations, Customer Care)
• Preparing reports summarizing complaint data for management review, complaint meetings and input to PSUR (Post Market Surveillance)
• Triage complaints on reportability in accordance to the specific regulations and report these complaints to applicable authority including follow-ups.
• Lead/support Field action (e.g.: Field Safety Corrective Actions, recalls) assessments and executions when needed.
• Report and maintain communication with authorities in a timely manner.
• Provide analysis and reporting of complaint data, enabling timely and informed decisions relating to product safety, product quality, and customer satisfaction.

External (Distributers)

• Liaise with distributors on complaints and feedback
• Support with development/maintenance/improvement on complaint tools (e.g.: complaint portals)
• Support with the development/maintenance/ improvement on training materials used by distributers
• Support in the set up of complaint and feedback processes with new markets

Wat vragen wij?

Education/Experience:

• Degree in a technical/scientific field/ equivalent experience
• Minimal 5 years working experience with complaint handling in the medical device industry
• Knowledge of global Medical Device Regulations (EU MDR and FDA), particularly 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 experience to organize, prioritize and follow through on multiple tasks with minimal supervision.

Desired:

• Complaint management software skills a plus. (i.e. Salesforce, Trackwise, PLM, etc.)
• Experience with health hazard evaluations, CAPA and hands-on experience with ISO 14971 is preferred

Wat bieden wij?

In addition to working on a ground-breaking new product, you’ll be working in a small, friendly and highly motivated team; all ideas are welcomed, and great work is rewarded. We’re also offering:

• A competitive salary based on your level of experience
• 32 days holiday per year (pro rata) + 5 optional purchase days
• An average 40 hours per week (part-time staff are also welcome) + flexibility to be available outside of hours
• Pension scheme
• Commuting allowance
• Discount on gym membership
• Bike Scheme
• Informal dress code
• Free, on-site parking
• Multi-cultural working environment
• A work environment where you can develop your skills, learn from the best and be rewarded for your imagination