Sr Regulatory Affairs Specialist (12 month Contract)
About Your New Employer
- Join a pioneering organization in Galway’s thriving med-tech sector, committed to quality and regulatory excellence.
- Experience a forward-thinking work environment that values autonomy, innovation, and collaboration.
- Work on impactful global projects with a hybrid model based Galway.
About Your New Job
- As the Senior Regulatory Affairs Specialist, you will coordinate and prepare document packages for regulatory submissions and audits.
- Lead the compilation of materials for submissions, license renewals, and annual registrations, ensuring full compliance with regulatory standards.
- Recommend process, labeling, manufacturing, and clinical protocol changes to drive regulatory compliance and continuous improvement.
- Interact with regulatory agencies as needed, recommending strategies for the earliest possible approvals for clinical trials.
- Mentor colleagues and, when required, direct and review the work of junior professionals.
What Skills You Need
- Bachelor’s degree required; master’s or higher preferred.
- Minimum 4 years of experience in regulatory affairs (or 2 years with a relevant advanced degree).
- Proven ability to deliver and manage complex regulatory projects independently.
- Advanced understanding of regulatory procedures, compliance frameworks, and project management.
- Strong communication skills for engaging with senior stakeholders and influencing decision-making.
What's on Offer
- Highly competitive salary: €64,000 – €80,000 pro rata.
- Hybrid working model with flexibility and work-life balance.
- 12-month contract – gain experience with industry-leading projects and access career development opportunities.
What's Next
Apply now by clicking the “Apply Now” button. For a confidential discussion or if you’d like to explore similar contract roles, please get in touch!
