Serosep Limited are currently recruiting a Regulatory Officer for a full time, permanent position here in Annacotty, Limerick.
Reporting to the Regulatory Manager
- Review project documentation and assist in risk management activities across multiple projects
- Assist in coordination and planning of post market surveillance/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.
- Min 2 years’ experience in a Medical Device or an In Vitro Diagnostic Company
- BSc in molecular biology or related discipline
- Working knowledge of ISO 13485 and ISO 14971 standards
- Ability to work to tight deadlines
- Good initiative and team player
- Full clean driver’s licence
- MSc in molecular biology or related discipline
- 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
Closing date for applications is 7th October, 2022