The Role
Leinster Appointments is currently recruiting for a permanent, full time Regulatory Affairs Officer in Co. Meath.
Permanent, full time role.
Hybrid - 2 days from home. For the first 4 months, it will be 1 day from home for training purposes .
Salary €50,000 - €80,000 and will depend on the candidates' experience
Main duties:
- Ensuring the Company’s products comply with all relevant regulations and standards
- Knowledge and execution of Type IA, IB and II Variations
- Licence transfers in various international territories
- Review of promotional material for medicinal products
- Preparation of Module 1 documentation for National Applications
- Prepare for and participate in meetings with Regulatory Authorities
- Deal with regulatory aspects of internationalising products and applying for reclassification of products
- Train and mentor more junior team members on Regulatory processes and compliance requirements
- Monitor and interpret regulatory trends and changes relevant to the industry and keep the Company appraised of these.
The Person
· Highly resilient and adaptable, able to work under pressure and within time constraints
· Drives results on a timely basis and sees things through to conclusion
· Knowledge of MRP, DCP, CP
· Knowledge of medical devices highly desirable
· Excellent attention to detail and organisational skills
· Capable of working on own initiative and taking responsibility for course of action
· 3-4 years previous experience essential
