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.
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