Senior Regulatory Affairs Specialist - 12 month contract
$69,034–$103,550 year
On-site · Galway, Connacht, Ireland
Job Summary
Senior Regulatory Affairs Specialist (12-month contract) based in Galway, Ireland. You will lead coordination and preparation of document packages for regulatory submissions, support change control for global approvals, compile materials for submissions and renewals, collaborate with international regulatory staff and engineers to develop regulatory strategies, and recommend labeling, manufacturing, and clinical protocol/evaluation changes for regulatory compliance. You will stay abreast of regulatory changes, develop internal procedures to ensure ongoing compliance, and may interact with regulatory agencies. Requires strong regulatory experience in medical devices (preferably Class III), knowledge of FDA requirements and EU MDR (Regulation 2017/745), and ability to manage multiple projects with cross-functional teams.
Required Qualifications
- Minimum NFQ Level 8 Bachelor’s degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field with minimum 4 years of relevant experience in medical device industry, preferably with Class III devices
- Or Master’s degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field minimum 2 years of relevant experience in medical device industry, preferably with Class III devices
- Regulatory experience in Medical Devices, Pharmaceuticals, Software in a medical device or similar regulated industry is required
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