Sr Regulatory Affairs Specialist
4 weeks ago
At 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 4 years of relevant experience. A Regulatory Affairs qualification is desirable, but not mandatory. Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required A dynamic team player and can work effectively and pro-actively on activities both individually and in teams. Strong technical knowledge. You are skilled in thinking critically and making sound decisions. Ability to comprehend principles of engineering, physiology, and medical device use. 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. Provide guidance, coaching and training to other employees within job area. 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. Medtronic offer a competitive salary and flexible Benefits Package #IJ 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 90,000+ 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 here To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.
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