Regulatory Affairs Specialist II - HYBRIDCo. WexfordOur client is a well established multinational MedTech corporation, with an R&D Centre of Excellence based in the Wexford region.This organisation is most recently renowned for achieving HUGE investment from an Irish Foreign Direct Investment Agency, for expansion of the Wexford facility, worth over €5 millionWhy Apply for this Role?Competitive package with private pension, private health care, life assurance and moreHYBRID - 2 days remote working per weekHuge opportunity for personal development and progressionOpportunity for career travel with two fully expensed international trips per yearKey Responsibilities:Develop and maintain regulatory strategies for new and modified product/product familiesPrepare and implement regulatory filings, including technical files, Canadian submissions, and letters to file.Provide regulatory guidance on changes to existing productsProvide regulatory input to support post-market surveillance and vigilance activitiesKey Requirements:Bachelor's degree in Engineering or Scientific related discipline3+ years experience in a Quality/Regulatory Affairs role within the MedTech or IVD industryExperience with pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval.