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Senior Regulatory Affairs Specialist, Galway Client:
Location: Galway, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 416bb92e5e5e
Job Views: 5
Posted: 18.06.2025
Expiry Date: 02.08.2025
Job Description: Our client, a Galway-based multinational, is looking to hire a Senior Regulatory Affairs Specialist on an initial 12-month contract.
Responsibilities: Coordinate and prepare document packages for regulatory submissions.
Support change control activities for global approval and implementation of product and process changes.
Compile materials for submissions, license renewal, and annual registrations.
Collaborate with regulatory specialists and international staff to develop regulatory strategies and address agency questions.
Recommend label and documentation changes to ensure regulatory compliance.
Stay updated on regulatory procedures and ensure internal procedures comply with requirements.
Interact with regulatory agencies as needed.
Support compliance activities, including manufacturing site registration and GMP audits.
Develop best practices within the Regulatory Affairs Department.
Requirements: Level 8 Honor's Degree in Science or Engineering; minimum 5 years of relevant experience, preferably with Class III devices.
Regulatory Affairs qualification is a plus.
Experience in Medical Devices, Pharmaceuticals, or Software in a regulated industry.
Effective team player with proactive work approach.
Strong technical knowledge and understanding of engineering, physiology, and medical device use.
Experience working with FDA, EU MDR, Regulation (EU) 2017/745, and other international agencies.
Ability to guide, coach, and train colleagues as needed.
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