About Vi Centra
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 Vi Centra, 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!
Vi Centra 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
Vi Centra is looking to hire a Senior Post-Market Surveillance Specialist to join our vibrant organization. In this position you will play a key role in leading post-market activities in compliance with regulatory requirements such as EU MDR and FDA guidelines. Additionally, you will offer extensive regulatory affairs support to project teams and contribute to other regulatory initiatives as needed.

Main Responsibilities include but are not limited to:

• Plan, conduct and report on post market surveillance activities to support Vi Centra’s manufacturer obligations under the MDR, FDA and other applicable regulatory requirements.
• Triage complaints on reportability in accordance to the specific regulations and report these complaints to applicable authority including following ups.
• Report and maintain communication with authorities on a timely manner.
• Provide analysis and reporting of complaint data, enabling timely and informed decisions relating to product safety, product quality, and customer satisfaction.
• Preparing Health Hazard Evaluation(HHE), corrections and field safety corrective actions documents.
• Lead/support Field action (e.g.: Field Safety Corrective Actions, recalls) assessments and executions when needed.
• Compiling databases of research.
• Reviewing promotional and advertising materials, complaints and lead vigilance and MDR reporting efforts.
• Accomplish goals by accepting ownership; exploring opportunities to

add value to job accomplishments.

• Reviewing and advising on labelling, product claims, training materials, publications, press releases or marketing programs to ensure compliance with regulations.
• Advising on international product registration and export approval requirements.
• Ensure work is undertaken within defined timescales.
• All work to be undertaken and completed with a high level of accuracy and attention to detail.
• Working independently with minimal supervision as well as ability to work closely with the wider Quality team, Customer support, Operations and R&D.
• Ensure compliance with all regulatory, legal and Company policies and procedures.
• Support regulatory and quality systems management.
• Perform other duties as needed, assigned by the Senior Regulatory Affairs Manager.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Ensuring that quality standards are met and submissions meet strict deadlines.

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, vigilance and field safety corrective actions in the medical device industry
• Rich experience in the field of complaint handling and vigilance activities in a medical device environment, e.g. experience in medical QMS (e.g. ISO 13485)
• Strong analytical and reporting experience
• Proven ability to work independently, prioritize multiple projects, address multiple issues in a hands-on, timeline driven environment.
• Strong professional ethics and integrity, sound judgment and the ability to take decisive action
• Knowledge of global Medical Device Regulations (EU MDR and FDA), particularly in relation to complaint handling and adverse events.
• Pragmatic, accurate, analytical, enjoying a mix of activities in regulatory and clinical challenges.
• Working knowledge of medical device regulations, requirements, and standards including 21 CFR 820, ISO13485, ISO 14971, 2017/745 and EEC 93/42.
• Strong IT skills, including but not limited to MS Office (advanced user)

Desired:

• Knowledge on Diabetes Type I
• Start-up/Scale up experience
• Software skills in i.e. Salesforce, trackwise, power BI, Tableau, etc

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 and additional 8% holiday allowance
• 25 days of holiday per year and the opportunity to take the Dutch national holidays on any day that suits you
• Flexible working hours and hybrid working options to divide your time between working from the office and working from home
• A partially company subsidized pension scheme
• Subsidized gym membership and the opportunity to participate in a tax friendly bike scheme
• A work environment where you can develop your skills, learn from the best and be rewarded for your imagination
• Meaningful work with the opportunity to make a difference in the lives of people with diabetes

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.

Vi Centra 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 Vi Centra 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 Vi Centra or Vi Centra employees. Where this is not observed Vi Centra reserves the right to contact these candidates directly and initiate discussions without payment of any agency fee.