Our Client a leading Medical Device Company in Limerick is hiring a Regulatory Specialist. This role will provide ongoing support to the regulatory team and assist with the transition of new requirements in 2025
Responsibilities include but are not limited to the following:
Assist in the IVDR project, representing regulatory team on cross-functional teamEnsure employees understand their duties/delegated tasksRepresent the regulatory team on all new product development and change control to ensure device is compliant to appropriate regulatory requirementsReview all project documentation across multiple projects and final sign off as regulatory representativeEnsure all deadlines are on target/metPrepare and maintain IVDR compliant technical files utilising information from cross functional teams for IVD Products (class a – d)Track and control all regulatory submissions for product changes or renewals for device certificationCoordination of risk management activities and documentation for CE-IVD marked productsApprove labelling (labels, instructions for use) for compliance with applicable regulatory requirements and international standards, including UDIReview complaints for regulatory reporting for CE-IVD marked productsPrepare reports for the Quality Manager/Senior Management as requiredBSc in Molecular Biology or a relevant discipline.3+ years experience working in a Medical Device or In Vitro Diagnostic CompanyExcellent communication and interpersonal skillsAbility to manage competing priorities in a fast-paced environmentStrict attention to detail in all aspects of the roleAbility to work to tight deadlines
Desirables : Experience in preparation and maintenance of medical device technical files; MDD/MDR experience and/or IVDD/IVDR experience; Experience with QMS and product audits from Notified Bodies
This role will offer great benefits including a hybrid working model to the successful candidate.
Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.
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