Regulatory Affairs Specialist

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 LifeMedtronicAt 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 PurposeAt 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 (SH) business.Come for a job, stay for a careerA Day in The Life Of:Directs or performs coordination and preparation of document packages for regulatory submissions.Teams with other Regulatory Affairs Specialists and international regulatory specialists to provide regulatory support for changes to existing products.Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.Leads or compiles all materials required in submissions, license renewal and annual registrations.Supports change control activities to support global approval and implementation of product and process changes.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 direct interaction with regulatory agencies on defined matters.Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.Monitors and improves tracking/control systems.Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.Key Skills & ExperienceWe are looking for a person qualified to Level 8 Science or Engineering honours bachelor's degree and minimum of 2 years of relevant experience.Regulatory Affairs qualification is desirable, but not mandatory.Regulatory experience in Medical Devices and/or Pharmaceuticals is required.You are a dynamic team player and can work effectively and proactively on activities both individually and in teams.You have strong technical knowledge.You are skilled in thinking critically and making sound decisions.You collaborate with others and create alignment with team members.You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behaviour.Ability to work independently and under general direction only.Strong proficiency skills with I.T systems and data collection.Medtronic offer a competitive salary and flexible Benefits Package#IJPhysical Job RequirementsThe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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 MedtronicWe 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.