Position:
REGULATORY OFFICER
Location:
Annacotty, Limerick

Serosep Limited are currently recruiting a Regulatory Officer for a full time, permanent position here in Annacotty, Limerick.

 

Reporting to the Regulatory Manager

 

Main Duties:

  • 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.

 

Essential Criteria:

  • 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

 

Desirable Criteria:

  • 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

Apply for position