FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals.
Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.
Senior Regulatory Affairs Specialist, Global Markets
Location: Gort, Co. Galway (Hybrid – 2–3 days onsite per week)
Function: Quality Assurance & Regulatory
Reports to: Regulatory Affairs Manager
We're looking for an experienced Senior Regulatory Affairs Specialist to join our growing organisation in Gort, Co. Galway. This is an exciting opportunity to play a pivotal role in bringing innovative medical technologies to patients around the world while helping drive regulatory excellence across a global organization.
If you're a strategic regulatory professional who thrives in a collaborative environment and enjoys navigating complex international regulations, we'd love to hear from you.
The Opportunity
As a Senior Regulatory Affairs Specialist, you will lead and coordinate global regulatory activities for both new and existing products, ensuring compliance while enabling timely market access. You'll work closely with cross-functional teams including Quality, R&D, Clinical, Marketing, and Operations to help bring life-changing technologies to healthcare providers and patients worldwide.
This role offers significant visibility across the organization and provides the opportunity to influence regulatory strategy at both project and business levels.
What You'll Be Doing
- Lead global regulatory submissions, renewals, registrations, and change management activities.
- Develop and execute regulatory strategies that support product approvals and business objectives.
- Ensure compliance with EU MDR, FDA, and other applicable international regulatory requirements.
- Partner with cross-functional teams throughout the product lifecycle.
- Serve as a primary contact with regulatory authorities on assigned matters.
- Assess regulatory implications of product, manufacturing, labelling, and process changes.
- Monitor changes in global regulatory requirements and drive organizational readiness.
- Support internal and external audits and inspections.
- Improve regulatory processes, systems, and documentation practices.
- Provide mentoring and regulatory guidance to colleagues and project teams.
What Success Looks Like
You are a confident regulatory professional who can balance compliance requirements with business needs. You have a strong understanding of global regulatory frameworks and enjoy building partnerships across technical and non-technical teams.
You bring a proactive, solutions-oriented approach and can translate complex regulations into practical guidance that supports innovation while maintaining compliance.
What You'll Bring
Required
- 5+ years of Regulatory Affairs experience within medical devices, pharmaceuticals, or life sciences.
- Strong knowledge of EU MDR and/or FDA regulatory requirements.
- Experience preparing and managing complex regulatory submissions.
- Demonstrated success leading cross-functional projects.
- Excellent communication and stakeholder management skills.
- Strong organizational and project management capabilities.
Preferred
- Experience supporting global product registrations.
- Regulatory Affairs certification (RAC) or equivalent.
- Experience working within a multinational medical device organization.
- Experience mentoring or coaching colleagues.
Why Join Natus?
- Make a meaningful impact on patient care through innovative neurodiagnostic technologies.
- Work on global regulatory initiatives that directly support product innovation and market expansion.
- Join a collaborative, highly skilled team that values knowledge sharing and professional growth.
- Enjoy a hybrid working model that supports flexibility and work-life balance.
- Access excellent career development opportunities within a global healthcare organization.
- Be part of a company with a strong mission, innovative culture, and long-standing reputation for excellence.
Benefits
- Competitive salary package
- Annual bonus opportunity
- Pension scheme
- Health Insurance
- Life Assurance
- Educational Assistance Program
- Employee Recognition and Rewards Program
- Sports & Social Club
- Flexible working arrangements
- Free onsite parking
- Career development and progression opportunities
Ready to Make an Impact?
Join a team dedicated to advancing neurodiagnostic care and helping clinicians improve lives every day.
Compensation and Benefits: Along with a competitive salary and bonus structure, we offer a comprehensive benefit package to start: Health & Life Assurance cover, defined contribution pension plan, active sports and social club, flexible work location, flextime (depending on position), excellent career progression opportunities, free parking, and educational assistance.
Be the People part of the Neuro Solution. Apply Today.
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.
