Principal 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. 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 ICT business. Come for a job, stay for a career! A Day in The Life Of: Engages with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing products. Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies. Directs and influences the preparation of documentation to support high quality regulatory submission dossiers. Leads regulatory filings to support submissions, license renewal and annual registrations.  Influence clinical evidence strategy to support labeling content, marketing claims and regulatory compliance.  Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes. Mentors and coaches’ other employees within the department and provides leadership support to ensure strong talent development. Keeps abreast of regulatory procedures and changes. Supports industry advocacy activity to shape the future of evolving regulatory requirements. Develops internal procedures to ensure continuous compliance with all regulatory requirements. Develops strategies for earliest possible global approvals of regulatory filings. Supports 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 7 years of relevant experience or advanced degree 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 collaborate with others and create alignment with team members, at times acting as a team leader 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 are a recognized expert, capable of managing large projects or processes.  You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior. You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills. 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