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Regulatory Affairs Officer

Reference:SGAXEM-685086 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: €45000 - €50000
May be suitable for: Regulatory Affairs

Regulatory Affairs Officer
Life Science Recruitment are exclusively sourcing a Regulatory Affairs Officer for our client who are based in Limerick. The ideal candidate will have a degree in molecular science with the ability and confidence to undertake all associated responsibilities.

Roles & Responsibilities
• Preparation & maintenance of technical information for product design history files (with R&D teams)
• Coordination of R&D phase reviews
• Coordination of change control and validation studies in collaboration with R&D/Validation Teams
• Coordination of post market surveillance/vigilance reporting
• Communication of specific regulatory requirements to cross functional teams.
• Preparation of regulatory reports for management as required

Skills & Experience

• Minimum BSc in molecular biology or related discipline with MSc & PhD being advantageous
• Good Knowledge & understanding of IVD Directive
• Good Knowledge & understanding of ISO 13485
• Good Knowledge & understanding of FDA 21CFR Part 820
• Ability to work on own initiative.
• Self-motivated and enthusiastic
• Excellent interpersonal skills
• Effective team worker
• Good command of English language (written & verbal)
• Good command of computer packages (e.g. MS Office)

If you would like further Information you can contact the recruiter directly:

Simon Gillivan | Tel: +353 (0) 1 507 9258