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. You will closely collaborate with manufacturing sites, distribution centres and international authorities.
Responsibilities• Involvement with submissions and administrations for the company’s products • Key contact person concerning Regulatory Affairs for internal and external stakeholders among which authorities and notified bodies • Creating awareness and spread of knowledge regarding RA related topics and procedures • Supportive and advisory role as team lead, and for subsidiaries of the organisation • Overviewing the ongoing changes and points of improvement for the Quality Management System and relevant, required documentation • Maintenance and controlling of the required regulation standards and legislation • Follow up on the latest developments for Medical Device regulation and creating strategies to apply these regulations • Development of trainings and exchange of knowledge across teams and other departments • Leader during internal and external audits from the beginning to the end of the process, and making reports of these audits
Requirements• Bachelor in the Life Sciences • Minimal 2 years of experience in the Medical Devices sector • Minimal 1 years of experience in a RA role • Excellent knowledge of the Medical Device Directive, and preferably the MDR and IVDR • Excellent writing and verbal skills in English • Experience with international registrations for countries as USA, Canada, Asian countries and South American countries is a plus • Knowledge of the ISO 13485, particularly the 2016 norm • Strong analytical skills and eye for detail • Team player, yet individual operator
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