Regulatory Affairs Specialist II - HYBRID
Co. Wexford
Our 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 million
Why Apply for this Role?
* Competitive package with private pension, private health care, life assurance and more
* HYBRID - 2 days remote working per week
* Huge opportunity for personal development and progression
* Opportunity for career travel with two fully expensed international trips per year
Key Responsibilities:
* Develop and maintain regulatory strategies for new and modified product/product families
* Prepare and implement regulatory filings, including technical files, Canadian submissions, and letters to file.
* Provide regulatory guidance on changes to existing products
* Provide regulatory input to support post-market surveillance and vigilance activities
Key Requirements:
* Bachelor's degree in Engineering or Scientific related discipline
* 3+ years experience in a Quality/Regulatory Affairs role within the MedTech or IVD industry
* Experience with pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval.