Role DescriptionIn this position you will be responsible for preparing and coordinating regulatory submissions and documentations for the EMEA region. You will do this in cooperation with the RA team located in Maastricht and other offices both in EMEA and Globally. Your primary responsibility is to ensure regulatory compliancy for your assigned (and new) product line. The new RA specialist will have a dynamic job within the organisation where you will as well support recalls, identify requirements and relevant standards for submissions and registrations, assisting with audits, conducting internal audits and assess plus recommend MDD/MDR action course.
ResponsibilitiesResponsibilities will include but not be limited to: - Participates in and cooperate with various teams to define regulatory requirements for EU international submissions within the EMEA region. - Identify guidance documents, international standards, consensus standards and assists teams with their interpretation. - Prepare regulatory submissions to regulatory authorities. - Assist with analysis and making recommendations regarding complaints - Performs other related duties and tasks, as required.
Requirements- Strong knowledge of Medical Device regulatory requirements - Industry experience in Medical Devices or Pharmaceuticals - Knowledge of ISO 13485 and FDA 21 CFR 820 (depending on Regulatory industry experience a preference) - Strong interpersonal and communication skills -- verbally and in writing -- with others - Motivated to work within an innovative international medical device organisation where you are able to make a difference!
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.