Regulatory Officer

Republic of Ireland, Limerick
€35000.00 - €45000.00 per annum
09 Jun 2021
07 Jul 2021
JN -022021-166500
Lisa Cullinane
Contract Type
Full Time
Adecco have an amazing opportunity for a Regulatory Officer to join a leading Med Device company-based in Limerick City. In this role you will be responsible for preparing and maintaining technical files and utilising information from cross-functional teams

Roles & Responsibilities:
*Review documentation and participate in R&D Phase Reviews
*Aid in coordination of Risk Management activities and file preparation
*Aid in coordination of Post Market Surveillance / Vigilance Reporting
*Communicate specific regulatory requirements to cross functional teams
*Prepare Regulatory Reports for Management as required

Skills Required:
*Qualification: BSc molecular biology or related discipline
*Good Knowledge & understanding of IVD Directive/Regulation or Medical Device Directive/Regulation
*Experience working in ISO 13485 and FDA regulated companies
*Ability to work on own initiative
*Good command of Microsoft Office

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.

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