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 The Principal Regulatory Affairs Specialist is responsible for providing regulatory leadership and strategic support for product development, lifecycle management, and global market access activities for the Shiley product portfolio. This role partners cross-functionally with R&D, Quality, Manufacturing, Clinical, Marketing, Operations, and globalization regulatory teams to develop and execute regulatory strategies that support business objectives while ensuring compliance with applicable global regulations and standards. The individual in this role operates with a high degree of independence, influences cross-functional decision-making, and may serve as the regulatory lead for complex projects, product portfolios, or business-critical initiatives. 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 This role entails developing and implementing regulatory strategies, managing regulatory submissions and internal documentations, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members, supporting their development and helping them navigate complex regulatory requirements. Collaborate closely with cross-functional partners such as R&D, clinical, operations, and marketing to ensure regulatory needs are integrated into product development and lifecycle management. Occasionally represent the company in discussions with regulatory bodies and industry groups, supporting regulatory compliance and business objectives supporting Acute Care & Monitoring achieve regulatory success and maintain a competitive edge. Come for a job, stay for a career! A Day in The Life: The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Shiley™ product within the Acute Care and Monitoring operation unit. Activities include participation in new product development and change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs, 510ks, letter-to-file) and supporting EU MDR implementation. The Pr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.
Responsibilities
may include the following and other duties may be assigned: Directs or performs coordination and preparation of document packages for regulatory submissions. Supports change control activities to support global approval and implementation of product and process changes. Leads or compiles all materials required in CE-Mark and FDA submissions, internal regulatory documentations, license renewal and annual registrations. Teams with other business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies. Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance. Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements. May have direct interaction with regulatory agencies on defined matters. Support regulatory compliance activities, including manufacturing site registration & QMS audits as needed. Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives. Key Skills &
Experience
Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 7 years of relevant experience, preferably with US and EU Class II Medical Devices. Regulatory experience in Medical Devices industry is required. You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams. You have strong technical knowledge. You are skilled in thinking critically and making sound decisions. Ability to comprehend principles of engineering, physiology, and medical device use. You collaborate with global cross functional teams and create alignment with team members.
Experience
with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
Experience
with disposable medical devices May provide guidance, coaching and training to other employees within job area. You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior. Ability to effectively manage multiple projects and priorities. Has an excellent attention to detail and are results oriented. Proven problem-solving skills with the ability to identify risks and escalate issues as appropriate. Good initiative and team player. Medtronic offer a competitive salary and flexible
Benefits
Package #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 AskHR@medtronic.com.
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: 86,720.00 EUR - 130,080.00 EUR | 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 AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com