Our Client a leading Medical Device Company in Limerick is hiring a Regulatory Specialist.
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).
Liaise with other departments on the relevant requirements for PMS and PMPF.
Review 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.
Coordinate/Update Design History Files/Technical Files/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 PMS/Vigilance role in a Medical Device or an In Vitro Diagnostic Company BSc in Biomedical Science/Engineering or related discipline Working knowledge of ISO 13485 and ISO 14971 standards Ability to work to tight deadlines Good initiative, team player & full clean driver's license 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.
Pale Blue Dot Recruitment - The Resource for the MedTech Workforce