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!
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!
- 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, …)
- 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
t +3215 21 11 04