Job Description
Senior Regulatory Affairs Specialist
Location
: Gort, Co.
Galway (Hybrid – 2–3 days onsite per week)
Function
: Quality Assurance & Regulatory
Reports to
: Regulatory Affairs Manager
Overview
We are seeking a Senior Regulatory Affairs Specialist to join our team in Gort, Co.
Galway.
This is a key role responsible for leading and coordinating global regulatory submissions across new and established products, ensuring full compliance with regional and international regulatory requirements.
This position offers the opportunity to work cross-functionally in a dynamic, patient-focused environment while contributing to strategic regulatory planning and execution.
Key Responsibilities
Lead the preparation, coordination, and submission of regulatory documentation for global product registrations, renewals, and variations
Ensure compliance with EU MDR/IVDR, FDA, and other applicable regulatory requirements
Develop and implement regulatory strategies to support timely product approvals and market access
Review and recommend changes to labelling, manufacturing processes, clinical protocols, and marketing materials
Act as a key liaison with regulatory authorities, managing communications and submissions on defined matters
Monitor evolving regulatory requirements and ensure organisational readiness and compliance
Drive improvements in regulatory tracking systems, processes, and controls
Provide technical leadership across cross-functional project teams
Translate complex regulatory requirements into clear guidance for non-specialist stakeholders
Mentor junior team members and support capability development within the team
Contribute to audit and inspection readiness (internal and external)
About You
5–8+ years' experience in Regulatory Affairs within the medical device, pharmaceutical, or life sciences sector
Strong working knowledge of EU MDR and/or FDA regulations
Proven experience managing complex regulatory submissions and cross-functional projects
Demonstrated ability to influence stakeholders and drive alignment on regulatory strategies
Excellent communication skills, with the ability to simplify complex technical topics
Strong organisational and project management capability
Proactive, solutions-focused mindset with the ability to anticipate risks and challenges
What You'll Bring
Deep regulatory expertise with a strategic outlook
Experience leading or contributing to large-scale, cross-functional initiatives
A collaborative approach aligned to a patient-first culture
High levels of accountability, agility, and teamwork
Why Join Us?
Competitive salary package with pension.
Health Insurance & Life Assurance coverage.
Educational Assistance Program.
Employee Rewards Program.
Excellent career progression opportunities.
Influence supplier strategy and long-term quality outcomes
Join an innovative organization shaping the future of neurodiagnostic and healthcare technology.
Work in a collaborative environment with strong opportunities for career development and professional growth.
Take full ownership of strategically critical categories with real business impact.
Be part of a collaborative, high-performing sourcing function shaping future capability.
EEO Statement: Natus Medical is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
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