Global Regulatory Strategist II - MDR/CE Submissions

Aerogen, Ireland's leading medical technology company, seeks a Senior Regulatory Affairs Specialist II (Strategic Regulatory) to shape global regulatory strategies and lifecycle management for innovative aerosol drug delivery products. You will collaborate with R&D, Quality, Legal, and Commercial teams to drive compliant product introductions and lifecycle improvements.

The role emphasizes MDR 2017/745 program leadership, CE marking, 510(k) filings, and regulatory due diligence, with senior