Careers that Change LivesThis position is part of the Global Regulatory Operations Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes. Primary responsibilities include providing day to day support of regulatory systems and projects including regulatory distribution control activities for U.S. product release using Global Trade Services (GTS) application in SAP, weekly and ad hoc reporting, tracking overall completion of activities, following established processes and escalating issues unable to be resolved to regulatory affairs manager. This role primarily interfaces with regulatory affairs teams, operating unit (OU) regulatory teams, regulatory operations teams, manager, and director.A role in MCRS offers unique experience opportunities, such as being part of a global team, collaborating with business partners throughout the company, visibility to global structures and impacts, and insight to various processes and functions across Medtronic.We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. A Day in the LifeReceive, process, and resolve queries from other parts of the core business to support U.S. product release (e.g., material creation, GTS license creation, blocked orders, UDI submission).Daily support coverage occasionally extends outside business hours and extended coverage during quarter end and mandatory year-end shutdown. Product release support includes but are not limited to:oLicense Creation - Validate and create GTS License according to the information provided by OU regulatory teams, approval documentation, internal/external systems.oGTS blocked orders – Review, categorize, and resolve blocked orders by absence or discrepancy of attributes e.g. material addition, classification, approval. Monitor and address appropriate stakeholders such as Operating Units, supply chain and customer care to ensure blocked orders management.oKeeping documental support up to date on various system SharePoint(s). oBeing accountable for all activities related to product release working with other Reg Ops SpecialistsoMaking suitable communications to cross functional support team – Master Data Management, Supply Chain, Sales, and Customer Service. oActive participation in the recurring meetings of the Change Advisory Board (CABs) established for each system used by the Reg Ops team and global projects as requested.oProvide training to OU RA stakeholders and less senior members of the team.Work within a variety of internal/external systems such as FDA systems, SAP/GTS, UDI RA portal, CalyxRIM, InSightDX, Enovia, Agile MAP, and Regulatory databases for managing changes and submissions·Responsible for actively participating in process monitoring, monthly metric reviews, lean sigma/A3 DMAIC, and CAPAs projects within the department to improve processes.This includes identifying, analyzing, and implementing metrics to enhance business efficiencies.·Support internal/external audits and lead the verification process of standard operating procedures and work instructions ensuring that they reflect the current operations·Basic understanding of regulatory requirements, approach for researching detailed requirements, and keeping up with changes in regulations and applicable guidelines. Must haves Bachelor's degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience.2 years of relevant experience in regulatory affairs or related areas.Fluent English level.Knowledge or experience with SAP/GTS.Strong organizational skills and effective time management skills.Professional presentation, interpersonal, and advanced communications skills (written and oral)Highly detailed orientated and possess strong analytical skills to evaluate complex technical information.Document interpretation, queries and workflow skills.Flexible with changing priorities and works well under pressure in a fast paced, dynamic environment. Self-motivated, strategic thinker, team player, strong work ethic, tactful, exercises independent judgment and sound decision-makingKnowledge in MS Office.Knowledge in Excel.Ability to work in matrix structured organization. Nice to haves Nice to Have professional presentation communications skills for small to mid-sized groups.Nice to have Regulatory affairs or quality experience in medical devices or pharmaceutical industry.Nice to have job experience as Associate Regulatory Affairs Specialist.High understanding of market and laws for medical devices in global processes.
