Regulatory Operations Specialist

COS Medtronic Shared Services Americas S.A.S. • Full-time • COL-DC Bogota Calle 25G, Colombia • 1w ago

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

Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health, and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world.
This 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, 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. This role is remote based in Colombia.

Responsibilities may include the following and other duties may be assigned:

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

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. 

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