Regulatory Officer

Our Client a leading medical device company in Limerick is hiring a full time Regulatory Officer.
The successful candidate will report to the Quality Manager.Responsibilities include but are not limited to the following:Coordination and planning of Post Market Surveillance (PMS) activities and reporting, including Post Market Performance Follow up (PMPF).Assist in preparation of regulatory submissions for specific target markets for product changes and re-registrations as required.Liaise with other departments on the relevant requirements for PMS and PMPF.Review and analyse to ensure the outputs meet the applicable regulatory requirements.Reviewing complaints, CAPAs and non-conformances for regulatory reporting for CE-IVD marked products.Coordination and planning of vigilance activities, including Manufacturer Incident Reporting, correspondence with Regulatory Bodies and recalls/mock recalls, as required.Coordinate review of new and maintain existing Regulatory files for distribution business of the organizationCoordinate update of Design History File/Technical File/Risk documentation with post market data.Assist in review and approval of artwork (labels, Instructions for use) for compliance with applicable regulatory requirements and international standards, including UDI.Review change controls for impact on regulatory compliance.Monitor changes in legislation, standards and guidance documents related to products and present findings to cross functional teams, as required.Min 2 years' experience in a Medical Device or an In Vitro Diagnostic CompanyBSc in molecular biology or related disciplineWorking knowledge of ISO 13485 and ISO 14971 standardsExperience with Post Market Surveillance and Vigilance activitiesAbility to work to tight deadlinesGood initiative and team playerFull clean driver's licenseDesirables: Experience in preparation of medical device technical files and regulatory submissions; MDD/MDR experience and/or IVDD/IVDR experience; Experience with QMS and product audits from Notified BodiesNote: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce