Posted: 12h ago
The role
Regulatory Affairs Specialist (12-Month Contract)
About Your New Employer
Join a renowned company in the medical device sector, based in Galway
Be part of an innovative, global organization recognized for its commitment to compliance, quality, and professional development.
Collaborative, forward-thinking environment where your expertise directly impacts regulatory excellence.
About Your New Job
As the Regulatory Affairs Specialist, you will:
Prepare and coordinate document packages for regulatory submissions across the organization.
Lead the compilation of materials required for submissions, license renewals, and annual registrations.
Advise on labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
Monitor and enhance tracking/control systems, staying current with the latest regulatory changes.
Interact with regulatory agencies on defined matters and recommend strategies for timely approvals.
What Skills You Need
University degree (Bachelor’s or higher) is essential.
Minimum 2 years of relevant experience (or advanced degree with 0 years' experience) in regulatory affairs or a related field.
Demonstrated competence in handling regulatory submissions and document management.
Strong communication skills and ability to collaborate across teams.
Experience in medical devices or regulated industries is an advantage.
What's on Offer
Competitive pro rata salary
12-month contract with hybrid working model for work-life balance.
Opportunity to make a real impact in a dynamic industry and develop specialist expertise.
What's Next
Apply now by clicking the “Apply Now” button or contact our recruitment team for more details. If this role isn’t quite right but you’re considering a move in regulatory or quality roles, please get in touch—exciting opportunities await. Email afitzpatrick@sigmar.ie or call +353 21 4847136
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