Global Regulatory Strategist II – MDR/CE Submissions

Aerogen Ltd.

Galway

Hybrid

EUR 90,000 - 130,000

Full time

8 hours ago

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Benefits offered by this job

Excellent medical care

Bonus & Pension

Aerogen Connect – employee programme

1% profits to charity

Job summary

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

Qualifications

Six to nine years hands-on regulatory affairs experience.
Proven track record in regulatory affairs, quality management, or related disciplines within medical devices.
In-depth knowledge of ISO 13485, MDR 2017/745, FDA QSMR, MDSAP; MDR amendments.

Responsibilities

Define global regulatory strategies across product lifecycle.
Lead regulatory due diligence for acquisitions and assess compliance risks.
Manage CE marking submissions and Notified Bodies interactions.
Coordinate with cross-functional teams—R&D, Regulatory, Legal, Quality, Operations.
Support MDR program execution and regulatory responses for 510(k) filings.