Regulatory Affairs Specialist

Medtronic Career OpportunityAt 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 LifeDrive product registrations, maintain licenses, ensure post-market compliance, and act as a crucial bridge between local commercial teams and regional regulatory bodies to guarantee patient access to life-saving medical devicesThis role is responsible for driving product registrations, maintaining licenses, and ensuring ongoing post-market regulatory compliance. The position serves as a critical bridge between local commercial teams and regional regulatory bodies to ensure timely patient access to life-saving medical devices.Responsibilities may include the following and other duties may be assigned.Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.Leads or compiles all materials required in submissions, license renewal and annual registrations.Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.Monitors and improves tracking / control systems.Keeps abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Recommends strategies for earliest possible approvals of clinical trials applications.Required Knowledge and Experience:Bachelor's degree required (or equivalent qualification in line with regulatory standards); advanced degree preferredMinimum 4 years of relevant experience in regulatory affairs within the medical device or healthcare industryWorking knowledge of regulatory requirements and submission processesExperience supporting product registrations, renewals, and compliance activitiesStrong organizational and documentation skillsAbility to manage multiple projects and timelines effectivelyExcellent English communication skills, with the ability to collaborate across teamsPhysical 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.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.Learn more about our business, mission, and our commitment to diversity here