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Responsible for preparing, reviewing, and coordinating local regulatory submissions and related activities for clinical trials across multiple countries.

Responsibilities

Prepare, review and coordinate local regulatory submissions (MoH, EC, gene therapy approvals, viral safety dossiers, import license)
Provide local regulatory strategy advice to internal clients
Coordinate SIA services and projects
Act as key contact for ethical or regulatory submissions at country level
Coordinate with internal departments to align site start‑up activities with submissions

Requirements

Bachelor's degree or equivalent

Skills

regulatory submissions MoH EC gene therapy approvals viral safety dossiers import license local regulatory strategy

Staff Engineer, Quality Assurance

Stryker · Posted Nov 4, 2026

Open

Carrigtwohill, County Cork, Ireland +1 more
€54K–€90K per year
4+ years

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Locations (2)

Carrigtwohill, County Cork, Ireland
Cork, Munster, Ireland

Compensation

Ireland: €54,000 - €90,000 EUR Annual

Responsibilities

Work closely with Operations and business functions providing oversight and direction on quality performance of product and processes
Collaborate cross-functionally with internal and external teams to resolve quality issues
Manage internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
Own and coach others in Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
Disposition of non-conforming product through MRB, issuing NCs as appropriate

Requirements

Honours Bachelor’s Degree - Science/Engineering

MoH jobs

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Locations (2)

Compensation

Responsibilities

Requirements

Skills