workday
Posted 3 days ago
Principal Regulatory Affairs Specialist
Job description
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 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
Skills and functions
- Marketing