To support our strategy we are strengthening our regulatory affairs team with an RA Officer position.
- You support the sales of our company established diagnostic products by obtaining and maintaining world-wide licenses in line with applicable regulations. You collect necessary data and coordinate submission and follow-up of registration/renewal files.
- You act as contact person for the authorities and other internal/external partners concerning the status and follow-up of a product registration
- You assist in the preparation of incident reports based on the information provided by RA representative of the Risk Assessment Committee, and you will follow-up on incident reports within the required timelines and in accordance with the regulatory requirements.
- You will be responsible for the maintenance of the regulatory intelligence databases
- Your job will involve interaction with various internal/external partners (affiliates, distributors, competent authorities, notified body, RA consultants, ...)
- Bachelor degree in medical or life sciences or equivalent by experience
- Strong interest in regulatory frameworks
- 2 à 3 year of regulatory affairs experience is a plus
- Accurate and reliable administrative skills
- Good knowledge of MS office Word and Excel
- Positive and pro-active attitude
- Good problem solving – problem analysis
- Communication with impact: good advisory skills
- Languages: Dutch & English – good knowledge written & spoken.