Medtronic busca personas para el cargo de Associate Regulatory Operations Specialist en Bogotá, Distrito Capital, Colombia | LinkedIn (2024)

Careers that Change LivesPosition can be remote in the United States or Colombia/Bogota.

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, operating unit (OU) regulatory teams, regulatory operations teams, manager, and director. This position is remote and open to candidates in United States or Latin America.

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 LifeResponsibilities 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(s).
• Being accountable for all activities related to product release working with other Reg Ops Specialists and Coordinators
• Making suitable communications to cross functional support team – OU RA, Master Data Management, Supply Chain, Sales, and Customer Service.
• Active 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.
• 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 verification process of standard operating procedures and work instructions ensuring that they reflect the current operations

Must Have: Minimum Requirements

• Bachelor's degree

Nice to Have

• Bachelor’s degree in sciences, engineering, or field related experience.
• Fluent English level.
• Prior experience with ECC or GTS system applications in SAP.
• 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-making
• Knowledge in MS Office.
• Knowledge in Excel.
• Ability to work in matrix structured organization.

About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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. Learn more about our benefits here . This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here . The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.