Regulatory Affairs Associate

Employment Type

Full time

Experience

Associate

Job Function

Quality

“We exist to create innovative products that give people more time to enjoy life. We do things differently, but only when that difference is meaningful. Our goal is to be a company people know they can rely on, a friend that’s on their side.”

The ViCentra group is an innovative group of medical device companies based in Utrecht, The Netherlands, comprising ViCentra B.V. and ViCentra Manufacturing B.V. ViCentra B.V. is the home of Kaleido, the smallest and lightest insulin pump system available; designed to help people with diabetes live life on their own terms.

We’re seeking a Regulatory Affairs Associate to join our talented ViCentra family in Utrecht, The Netherlands. This is a fantastic opportunity to have a varied, interesting role and work within a dynamic, innovative culture; rapidly challenging and broadening your skills and developing your career.

The position

You will be part of the Regulatory team, acting as the link between the Company and regulatory authorities, ensuring our product is manufactured and distributed in compliance with appropriate legislation.  The duties for this role include:

  • Compile and maintain clinical evaluation reports for the Company’s product(s).
  • Compiling databases of research.
  • Plan, conduct and report on post market surveillance activities to support ViCentra’s manufacturer obligations under the MDR and other applicable regulatory requirements.
  • Support administration, implementation and review of any clinical or usability investigations and post market clinical follow-ups
  • Support regulatory and quality systems management.
  • Conduct research interpretation and analysis of relevant markets for commercial and regulatory impacts.
  • Planning, undertaking and overseeing product trials and regulatory inspections
  • Keeping up to date with changes in regulatory legislation and guidelines
  • Liaising and negotiating with regulatory authorities
  • Ensuring that quality standards are met and submissions meet strict deadlines

The ideal candidate to join our team should have:

  • Previous experience within a Regulatory Affairs role
  • Strong analytical and reporting skills
  • Solution focussed with a high level of self-motivation, drive and tenacity
  • Strong admin and IT skills, particularly Microsoft Office
  • Confidence working in a fast paced environment
  • Fluent written and spoken English. Dutch language is not required.
  • Good communication skills
  • Exceptional attention to detail
  • Ability to work independently and prioritise work

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 very competitive salary
  • Full time (40 hours per week) 8 hours per day to be worked anytime between 07:00 to 19:00 Monday to Friday
  • 37 days’ holiday per year (pro rata)
  • Contribution towards commuting costs
  • A work environment where you can develop your skills, learn from the best and be rewarded for your imagination
  • Social events and team lunches
  • Creative office vibe with a picnic area, beanbags and ping pong table
  • Informal dress code, we’re all about wearing flip-flops in the summer and boots in the winter!
  • Meaningful work with the opportunity to make a difference

 Even More!

Working in Utrecht you will be working in one of The Netherlands oldest cities with a beautiful medieval centre arranged around canals. Recently voted the most vibrant city in the country (with the largest University in The Netherlands) it is the fourth largest city in the country. It is situated in the centre of the country 48km south of Amsterdam (27 minutes by train) and as such is within easy travel of a number of cities and sights. Moreover, we have a work hard/ play hard approach and believe in creating a fun, exciting work environment so ping pong breaks, team lunches and outings are usual. The free coffee and snacks help too!

Apply today

To apply please use the link below or email your CV to recruitment@vicentra.com stating that you are applying for the position of Operator. For more information, please email the above address or call Sarah Lee on +31 (0) 88 3232 896.

**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**

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.