Regulatory Affairs Specialist

Brightwater

Cork

A leading Medical Device client in Cork is seeking an experienced Regulatory Affairs specialist to join it`s high performing team. You will be a key member of the group and required to demonstrate flexibility as priorities change. Main Duties. Support MTO site initiatives for all product continuous improvement projects, site to site transfers and design transfers. To develop regulatory strategies, prepare and support regulatory submissions for the sites range of medical devices. Maintain site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS, and other International Regulations. Manage implementation of change requests for impact on regulatory market filings, and update and manage global registrations where applicable. Preparation of regulatory submissions to FDA: 510(k), PMA supplements, Annual Reports and dossiers for other International Regulatory agencies. Maintain compliance and accuracy of CE Technical Files aligned with site initiated device and process changes. Monitor global market regulatory changes, advise and/ or implement changes to ensure compliance. Support the coordination and implementation of product labelling changes from a global regulatory perspective to ensure compliance with applicable regulations. Interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirement. Experience. Degree in an Engineering or Science discipline. 5 years experience in an RA role within an FDA and / or ISO 13485 regulated medical device environment. Proven track record in writing Regulatory medical device submissions with the ability to successfully manage projects to deadlines. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2167 days ago