Senior Regulatory Affairs Specialist - 12 month contract
Hybrid · Galway, Connacht, Ireland
Galway, Connacht, IrelandHybridContractSenior LevelMasters DegreeEnterprise
Type
Contract
Level
Senior Level
Education
Masters Degree
Company size
Enterprise
Job Summary
Senior Regulatory Affairs Specialist for a 12-month contract in Galway, Ireland. Lead regulatory submissions and document packages, support change control and global approvals, develop regulatory strategies with engineers, advise on labeling/manufacturing/clinical protocol compliance, interact with regulatory agencies, ensure GMP/audit readiness, and drive continuous compliance within Regulatory Affairs for ICT medical devices.
Required Qualifications
- Min 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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