Role DescriptionIn your role as Regulatory Affairs consultant, you will receive the responsibility to support and guide a project with the FDA. You will assist the team, other departments and external stakeholders. You will overview the documentation, participate in inspections, submissions and registrations. Next to that, you are involved in the development of strategic plans and the implementation.
Responsibilities• Key role for Regulatory Affairs for internal and external stakeholders among which authorities and notified bodies • Support in the administration, submissions and registrations of product documentation • Supportive and advisory role for the particular project • Maintenance and controlling of the required regulation standards and legislation • Leader during internal and external audits from the beginning to the end of the process, and making reports of these audits
Requirements• Bachelor or Master in Life Sciences • Experience with the MDD and preferably MDR • Excellent knowledge of CE-marking, FDA and 510 k. Submission • Experience with inspections, support in audits for both internal and external suppliers • Excellent writing and verbal skills in English • Knowledge of the ISO 13485, particularly the 2016 norm • Strong analytical skills and eye for detail
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.