Regulatory Affairs Specialist - IICo. Wexford - HybridGlobally renowned MedTech expansion following EU funding for R&D Centre of ExcellenceBackground:Our client is in search of a Regulatory Affairs Specialist - II to lead projects in new product development with experience in an IVDR or Med Device ISO13485 regulated environment.What's on offer?Lucrative package with pension, healthcare and moreOpportunity to work with experts in the field in a non-political work culture environmentClear career progression opportunities internallyKey Responsibilities:Lead projects for new product development projects, providing advice to development teamsProvide regulatory guidance on changes to existing productsProvide regulatory input to support post-market surveillance and vigilance activitiesAct as Subject Matter Expert within 3rd party and internal auditsKey Requirements:Regulatory Affairs experience in the In Vitro Diagnostic or Medical Device environment.Knowledge and application of 21 CFR 820 and ISO 13485 is required.Experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval.