The companyOur client is a professional Pharmaceutical, FMCG and Medical Devices organisation, based in West-Vlaanderen Belgium. This organization is internationally represented. They are one of the market leaders for the development of self-care products. They offer an extensive product portfolio and rapidly expanding.
Role descriptionIn your role as Regulatory Affairs specialist, you will gain the responsibility to collect, maintain and adjust technical files and relevant documentation. You will have a supportive role in creating awareness and exchange of knowledge about international regulations and changes. In addition, you interact with internal and external stakeholders and you will ensure that they are provided with the required information. Next to that, you are involved in the development of strategic plans which are related to the Regulatory Affairs and the implementation.
ResponsibilitiesOn a daily basis you are responsible for the collection and implementation of regulations in relation to the specification of various products. Furthermore, your tasks include:
• Active role in maintenance and (new) product registration for particular foreign markets
• Supportive role for both internal and external stakeholders about RA related topics
• Development and assessment of the documentation database
• Development and adjustment of strategic plans and assessment of procedures for verification and validation projects
• Supporting execution of evaluation and risk management procedures
• Application and implementation of international legislation and documentation
Requirements• Bachelor or Master
• Minimal 3 years of experience in the Medical Devices, pharmaceutical or cosmetics sector
• Minimal 1-2 years of experience in a RA role
• Preferably knowledge of the Medical Device Directive or Medical Device Regulation
• Excellent writing and verbal skills in English
• Preferably knowledge of GMP, GDP, ISO 13485, particularly the 2016 norm
• Strong analytical skills and eye for detail
• Team player, yet individual operator
Other informationAre you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.