Senior Regulatory Affairs Specialist page is loaded## Senior Regulatory Affairs Specialistremote type: Flexible Work Arrangementlocations: Galway, County Galway, Irelandtime type: Full timeposted on: Posted Todaytime left to apply: End Date: November 8, 2025 (18 days left to apply)job requisition id: R48697At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.# **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 is supporting the Structural Heart business.***Come for a job, stay for a career!*****A Day in The Life Of:*** 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 submissions, license renewal and annual registrations.* Teams with 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 labeling, 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 & GMP 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 5 years of relevant experience, preferably with Class III Medical Devices. A Regulatory Affairs qualification is desirable, but not mandatory.* Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated 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.* 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.* Proficient in data analysis techniques, including statistical modeling, trend analysis, and data visualization.**Medtronic offer a competitive salary and flexible Benefits Package****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.# **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.This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).# **About Medtronic**# 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.Learn more about our business, mission, and our commitment to diversity* **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 learningThese 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 careIt 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 settingis 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 .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.comTo request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com
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