About ViCentra

Worldwide, over 30 million people with diabetes are insulin dependent. This means they need insulin to manage their blood glucose levels. They can either give themselves multiple daily injections, or use an insulin pump, which administers insulin on a continuous basis all around the clock.

At ViCentra, we’re on a mission to design an insulin pump that delivers not just a best-in-class performance, but also gives our users an experience that empowers and excites them. Something a bit different from the usual medical experience!

It’s simple really: people with diabetes are people – not patients. Our philosophy is all about simplicity, helping to carry some of the weight of day-to-day diabetes management for the user, adding a splash of colour and a whole lot of freedom! Kaleido is one of the smallest insulin pumps in the world. We have 10 colour combos, from bright and joyful to sleek and chic. We want our users to wear their Kaleido proudly. Its size makes Kaleido discreet and easy to wear, so Kaleidoers can forget about diabetes (for a while, at least!) and focus on what truly matters - living their life on their own terms!

ViCentra was founded in 2013 in the Netherlands, and while we still call Utrecht our home, we’ve now branched out to France and Germany, too. We're gearing up to spread our magic even further, with concrete plans to extend across Europe in 2024. We are CE marked, with in-house development and manufacturing, a state-of-the-art HQ, and a diverse and energetic team hailing from over 30 countries worldwide! We’re backed by heavyweight investors like EQT, INKEF, Invest-NL, Partners in Equity, and Health Innovations, all helping us to launch our rocket ship journey and forge a steady course.

We’d love you to travel with us.

The position

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

The ideal candidate to join our team should be energetic, positive and pro-active!
You’ll also have:

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

What we offer

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

Apply today

**We will start interviewing successful candidates without delay, therefore please submit your CV as soon as possible. If we like what we see we will contact you, if we don’t contact you within 4 weeks we’ve probably proceeded with other candidates but don’t lose heart as we might reach out to you if we have a different role or project we think might be a match**

If you've got any queries feel free to call +31 (0) 88 250 2900.

ViCentra is an equal opportunities employer and welcomes applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age. Due to the international nature of the Company applications are only accepted in English and candidates must also have the right to work in the Netherlands.

Agencies: Please note ViCentra is committed to sourcing candidates directly and as such we do not accept speculative CV’s from agencies. We do however work with an approved list of preferred suppliers but in line with our Preferred Supplier List we only pay agency fees where we have a signed agreement in place and a position has formally been placed with the agency by a member of the HR team. We do not pay fees where speculative and unsolicited CV’s are submitted to ViCentra or ViCentra employees. Where this is not observed ViCentra reserves the right to contact these candidates directly and initiate discussions without payment of any agency fee.