Senior Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

At our Regulatory Affairs department in Medtronic, plc, based in Galway, our mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients we serve. Regulatory Affairs is a key function within the business, and this role supports the ICT business.

The Senior Regulatory Affairs Specialist will work primarily on software-based medical devices and will bring successful experience authoring software submissions through the FDA eSTAR programme and submissions to an EU Notified Body, together with a deep understanding of IEC 62304 and software lifecycle processes.

Come for a job, stay for a career!

• Prepare US and EU MDR submissions for new products and product changes to support timely approval for market release. Review significant regulatory issues with the Manager, as necessary, and resolve submission issues with Medtronic engineering partners, Geography Regulatory partners and regulatory agencies.
• Prepare regulatory strategies and plans, including worldwide compliance requirements. Provide ongoing support to project teams on regulatory issues and questions, and interpret and apply regulations and guidance appropriately.
• Provide business and product information to support development of regulatory strategies and requirements, and communicate that information to project teams.
• Provide regulatory support for currently marketed products, including review of labelling, changes to existing devices and associated documentation. Prepare submissions and reports for regulatory agencies as required.
• Apply a comprehensive understanding of technical and regulatory principles, theories and concepts, together with general knowledge of related disciplines.
• Engage and negotiate with international regulatory agencies, as needed. Review significant issues with the supervisor.
• Participate in project team meetings to plan regulatory strategies, including review of specifications, plans and reports; definition of target markets and distribution methods; and identification of Medtronic testing requirements.
• Provide regulatory analysis of the product portfolio and collaborate with other functions, including Marketing and Global Supply Chain. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Work under general supervision and established procedures, independently determining and developing the appropriate approach.
• Maintain frequent inter-organisational contact and appropriate external contacts.
• Keep current on global directives, harmonised standards and procedures, and communicate changes that may affect cross-functional areas.
• Provide training and support to other members of the department.
• Perform other tasks, as required.

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Minimum NFQ level 8 Bachelor's degree in a technical discipline with a minimum of 4 years of medical device regulatory experience or with an Advanced/Master’s degree with a minimum of 2 years of medical device regulatory experience.
• Experience working in a regulated medical device or biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies such as the FDA and PMDA, and working with cross-functional project teams.
• In-depth experience with FDA requirements and guidance documents, the EU Medical Device Regulation, IEC 62304, ISO 14971, ISO 13485 and other global regulatory requirements and quality standards.
• Working knowledge of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).
• Positive track record of engaging with regulators.
• History of successful medical device submissions.
• Strong negotiation and written and oral communication skills.
• Strong organisational and time-management skills.
• Ability to manage multiple projects, work globally, prioritise activities, conduct team meetings and meet project deadlines.
• Ability to work independently under general direction.
• Proficiency in Microsoft Office, Microsoft Project, Adobe Acrobat and Agile.

• Master of Science degree.