Excellent opportunity for aRegulatory Affairs Specialist to join a Medical Devices company on a 12 month contract in Galway. The Regulatory Affairs Specialist supports regulatory compliance activities across the product lifecycle, ensuring products meet regulatory requirements and achieve timely market access.
Overview of your responsibilities
Prepare and submit regulatory applications and product registrations.
Support license renewals and regulatory maintenance activities.
Coordinate regulatory documentation across cross-functional teams.
Support audits, inspections, and regulatory authority interactions.
Review labeling and product changes for regulatory compliance.
Maintain regulatory records and submission tracking systems.
Monitor changes in regulatory requirements and industry standards.
Knowledge, Skills and Experience Required for the Role:
Degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
3+ years' experience in Regulatory Affairs within MedTech or healthcare.
Strong knowledge of EU MDR, ISO 13485, and global regulatory requirements.
Experience preparing regulatory submissions and supporting inspections.
Strong communication, planning, and stakeholder management skills.
For a confidential discussion and more information on the role contactCourtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
