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.

REQUIRED KNOWLEDGE AND EXPERIENCE:

• Bachelor’s degree
• Two years of relevant experience in regulatory affairs
• Fluent in English
• Knowledge of MS Office
• Knowledge in Excel
• Ability to work in matrix structured organization
• Experience with SAP and GTS is required

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.

• Receive, 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:
• License Creation - Validate and create GTS License according to the information provided by OU regulatory teams, approval documentation, internal/external systems
• GTS 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
• Keeping documental support up to date on various system SharePoint
• Being accountable for all activities related to product release working with other Reg Ops Specialists
• Making suitable communications to cross functional support team – Master Data Management, Supply Chain, Sales, and Customer Service
• Provide 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