Regulatory Officer. Our client, a rapidly growing Irish organisation are now looking to further expand & the are looking for Regulatory Officer to join the team. This is a fantastic opportunity for a highly ambitious & suitably qualified regulatory candidate to further develop their career, so if youre interested, please apply! Main Duties: Review project documentation and assist in risk management activities across multiple projects. Assist in coordination and planning of post marketsurveillance/vigilance activities. Reviewing complaints for regulatory reporting for CE-IVD marked products. Prepare and maintain IVDR compliant technical files utilising information from cross functional teams for IVD products (Class A-D. Assist in preparation of regulatory submissions for specific target markets for new products, product changes and re-registrations as required. Participate as Regulatory Representative in cross functional team on design projects (molecular assay and software. Assist in review and approval of artwork (labels, Instructions for use) for compliance with applicable regulatory requirements and international standards, including UDI. Essential Criteria: Min 2 years experience in a Medical Device or an In VitroDiagnostic Company. BSc in molecular biology or related discipline or MSc in molecular biology or related discipline. Working knowledge of ISO 13485 and ISO 14971 standards. 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 Bodies. Experience with Post Market Surveillance and Vigilance activities. The Offer: The is a full time/permanent position with base salary, depending on experience/qualifications. How to Apply : If youre interested in applying or want to know more about this job 1st, contact Darren Brown in CPL Limerick in complete confidence on 087 405 3774 or email your CV email@example.com.
72 days ago