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eFlexes 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. Position will be offered on full time permanent basis and will report to Quality Manager. This role will also involve R&D Liaison with R&D teams.
Roles & Responsibilities
• Coordination of post market surveillance/vigilance reporting for CE-IVD marked products.
• Coordination of risk management activities and documentation for CE-IVD marked products.
• Communication of specific regulatory requirements and provide regulatory support to cross functional teams.
• Review and approval of Labelling (labels, Instructions for use, marketing material) for compliance with applicable regulatory requirements and international standards.
• Assist in preparation & maintenance of technical files for CE-IVD marked products and all other relevant documentation required to comply with the In vitro Diagnostic Directive, EU-IVDR and any other national or international regulations which apply to the company.
• Assists in planning and preparation of regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
• Preparation of regulatory reports for management as required.
• Performs additional duties as assigned.
Skills & Experience
• Minimum BSc or equivalent.
• Min 2 years' experience in a regulated industry in a similar role.
• Good Knowledge & understanding of IVD/MD Directive and IVD/MD Regulation
• 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)
eFlexes is an equal opportunities employer