Regulatory Affairs Specialist - II
* Co. Wexford - Hybrid
* Globally renowned MedTech expansion following EU funding for R&D Centre of Excellence
Background:
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 more
* Opportunity to work with experts in the field in a non-political work culture environment
* Clear career progression opportunities internally
Key Responsibilities:
* Lead projects for new product development projects, providing advice to development teams
* Provide regulatory guidance on changes to existing products
* Provide regulatory input to support post-market surveillance and vigilance activities
* Act as Subject Matter Expert within 3rd party and internal audits
Key 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.