Regulatory Officer

Adecco have an amazing opportunity for a Regulatory Officer to join a leading Molecular Diagnostics company-based in Limerick City (East). In this role you will report into the Director of Quality & Regulatory and 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

Specific 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
Desirable Criteria:
*PhD in molecular biology or related discipline
*Experience in preparation of medical device technical files and regulatory submissions
*Good problem-solving skills

Adecco Ireland is acting as an Employment Agency in relation to this vacancy.

Please apply with your CV to: Lisa Cullinane