Position:
Senior Regulatory Officer
Location:
Annacotty, Limerick

Full time, permanent position

Reporting to the Quality Manager

Serosep Ltd. have a requirement for a senior regulatory officer.  This person will be responsible for supporting all regulatory team members.  They will lead key elements of regulatory systems, ensuring compliance to relevant standards for the business including ISO13485 and FDA QSR.

 

Main Duties:

  • Drive quality culture in accordance with our quality policies, guidelines and processes
  • Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO 13485:2016 and IVDR: In Vitro Diagnostics Regulation)
  • Collaborate with the regulatory manager on all new IVDR regulations
  • Support implementation of company regulatory strategies and providing guidance and expertise.
  • Compiling and communicating regulatory requirements and gap analysis assessments (e.g. EU IVDR, global markets, standards, etc.) to multi-functional groups in a concise and precise manner.
  • Review and approve the project documentation (risk management documentation, design reports, labelling, etc.).
  • Ensure that updates to the Technical Files and international registrations are conducted appropriately.
  • Communicate with relevant departments should any issues arise
  • Ensure employees understand their duties/delegated tasks
  • Provide support to all regulatory team
  • Ensure any goals/deadlines are on target/being met

 

Essential Criteria:

  • A minimum BSc in molecular biology or related discipline and/or a minimum 5 years’ experience in a regulatory role
  • Min 2 years’ experience in a Medical Device or an In Vitro Diagnostic Company
  • Working knowledge of ISO 13485 and ISO 14971 standards
  • Experience with Post Market Surveillance and Vigilance activities
  • Ability to work to tight deadlines
  • Good initiative and team player
  • Excellent communication and interpersonal skills
  • 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

 

Closing Date : 21st April, 2024

Apply for position