Regulatory Affairs Coordinator IVD

For one of our clients, specialized in the IVD-technology , we received an interesting opportunity for a Regulatory Affairs Coordinator: 

  • Are you looking for a position that combines a strategic as well as a scientific approach in the Regulatory Affairs? 
  • You have at first experience with IVD or you have a strong knowledge of the regulations in the world of medical devices?
  • And are you fluent in English and up for a challenge? 

Then this is the perfect fit for you! 

Job Description 

For one of our clients, who is a specialist and pioneer in applications of vitro diagnostic medical devices, we are looking for an enthusiastic Regulatory Affairs Coordinator. 

This professional will have a wide variety of tasks, from set-up of the stratigic plan to the management of the technical and scientifical regulatory processes.

If an international work setting, a booming business and a work environment where you are challenged in a scientific and strategic manner sounds like music in your ears than this is the career you are looking for!

Responsibilities 
  • To set out a strategy to get IVD-R compliant (IVD-R, harmonized standards, REACH, IVD MEDDEV’s,…)
  • To Plan the execution of this strategy 
  • To be first contact for Notified Bodies and IVD-R related competent authorities
  • To execute UDI demands
  • To manage CE-Registrations (ISA-codes and IVD-R demands)
  • To manage QA Agreements (RA and technical input)
  • To communicate Technical IVD-R requirements to the Technical department (IFU content, MSDS, Design, Risk Management, Change Management, Validation, Verification, Clinical studies, CLP, …)
  • To develop and manage Protocols for that department (idem)
  • To do Product Risk Management (IVD-R, REACH – hazardous components, MSDS, Intended Use)
  • To do DMR/DHR-management
  • To do technical Change Management
  • To do technical Improvement
  • To set up, monitor and evaluate Technical KPI’s
  • To work together with the Technical Department on PMS
  • To set up and execute a Vigilance Management System
  • To execute IA for procedures RA is not involved
  • To execute Recalls
  • To have notions of International RA (FDA, …)
Profile 
  • You have a University Degree in Life Sciences (Master Degree or PhD)
  • You have at least one year of experience with Regulatory Affairs matters in the field of Medical Devices or IVD
  • You are fluent in English (oral and written communication), knowledge of Dutch is a plus
  • You have a hands-on mentality and a pragmatic attitude
  • You have a critical eye for quality and you have a strategic mindset
  • You can collaborate interdisciplinary 
  • You are looking for a stable work cooperation
  • You like to work in a booming business where you can use your scientific approach in the field of Regulatory Affairs
Contact Information 

Ellie Depape
t +3215 21 11 04
m ellie.depape@valesta.com

Application form : Regulatory Affairs Coordinator IVD

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