Role DescriptionIn your role as Interim Regulatory Affairs manager, you will be completely involved with creating strategies and developing plans to make sure that products are compliant in relation to required documentation and legislation for Europe. You will lead various types of audits among which internal, and distributor audits. You will lead your team in acting up on these audits, performing CAPA’s and creating tools for compliancy. Next to that, you will be the key person to contact for the establishment and maintenance of relationships with internal and external authorities.
Responsibilities• 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 • Over viewing 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 of Life Sciences • Minimal 2 years of experience within the Medical Device industry • Minimal 3 years of experience within a strongly regulated environment • Lead Auditor certification • Proven experience in building and maintenance of relationships with internal and external authorities • Excellent knowledge of Medical Device Regulation and standards for the European, Middle Eastern, African and Canadian market • Fluency in English and Dutch • Magnificent organisational and analytical skills • Excellent team player and communicator
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.