Associate 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 Life Responsibilities may include the following and other duties may be assigned Responsible for the preparation, system entry, publication, quality control, and delivery of paper and electronic components of regulatory submissions and overall regulatory information (initial, amendments, product life cycle updates) Submissions are produced with electronic publishing tools in compliance with document management standards. Regulatory information entries are managed using different regulatory systems and tools including data visualization dashboards and AI-assisted applications Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, project support, and providing input to systems designs Ensures continuous efficiency and effective process improvement measurements as part of KPI and value stream objectives, which also include but not limited to, project support, country-specific requirements compliance Prepares, submits, tracks, indexes and archives paper and electronic submissions and regulatory information including license details, amendments, annual reports, general correspondence, adverse event reporting, promotional materials, regulatory payment, and other regulatory technical and administrative data – in different regulatory systems and tools Required Knowledge and Experience Bachelor's Degree Required in Allied Sciences (Medical/ biological science/ Engineering or equivalent field) Language skills - English: Business level in reading, writing and speaking) Minimum of 1 year job experience in similar and/or related role Technology savvy – knowledge with power BI, Snowflake, RPA, or API is preferred Database and Regulatory Systems Management Good communication skills Scientific knowledge, must be able to read and understand the technical document such as test report, raw data, drawing etc. Computer skills (excellent knowledge of MS Office, Excel (V look), Word, affinity to computer systems (will use SAP, Calyx, RDR, etc.) and data management tools (PowerApps, Power BI - PREFERED) 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 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 #J-18808-Ljbffr