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. A Day in the Life Medtronic 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. Our Purpose 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! A Day in The Life Of 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. Key Skills & Requirements 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. Nice to Have Master of Science degree. Medtronic offers a competitive salary and flexible Benefits Package #INDJ #LI-Hybrid Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  ‌ ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected]. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 63,920.00 EUR - 95,880.00 EUR | The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework. ‌ This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

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