Regulatory Affairs Officer
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.
* This role will also involve R&D Liaison with R&D teams.
Skills & Experience
* Minimum BSc and 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
* Good command of English language (written & verbal)
* Strong computer skills
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.
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♦ The business of the Adecco Group UK & Ireland is transacted via a number of differently branded trading entities, as follows: Adecco UK Limited, Adia Technology Limited, Modis International Limited, Badenoch and Clark Limited, Ajilon (UK) Limited, Office Angels Limited, Penna plc, Pontoon Europe Limited, Roevin Management Services Limited, Spring Technology Staffing Services Limited.