We anticipate the application window for this opening will close on - 11 Feb 2025

 

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

Position can be remote in the United States or Bogota, Colombia.

This position is part of the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes. You will be a recognized specialist in FDA Device Listing and Establishment Registrations.  Primary responsibilities include supporting our Establishment Registration and Device Listing Value Stream team with day-to-day updates, annual registration and device listing reviews, audit support, provide consulting to our Operating Unit Regulatory Affairs teams and supporting ongoing projects.  

There are opportunities to also support our Unique Device Identification (UDI) system and teams to ensure data integrity in our regulated systems such as the Global Unique Device Identification Database (GUDID).  Duties may include data entry, data cleansing, submitting expense reports related to FDA Establishment Registration, supporting our Regulatory Affairs teams within the Operating Units and supporting audits and inspections.  

This role primarily interfaces with Official Correspondents including within the US and outside the US, 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.

Responsibilities may include the following and other duties may be assigned.
•    Responsible for activities related to the FURLS Device Registration & Listing Module including management, reporting, data entry and payments
•    Handles and resolves a projects, tasks or issues that may arise on a daily basis
•    Daily data entry activities
•    Managing expense reports for multiple locations and cost centers
•    Data mining and data cleansing activities
•    Understanding of FDA Title 21 CFR Part 807
•    Responsible for participating in lean sigma/A3 DMAIC projects within the department to improve processes.  This includes identifying and implementing metrics to enhance business efficiencies.

Must Have: Minimum Requirements 

•    Bachelor's degree plus 10+ years of relevant experience which can be data management or administrative experience (or advanced degree plus 8+ years of experience)

Nice to Have 
•    Experience in DLRM FURLS system
•    Experience interfacing with FDA
•    Comfortable working with upper leadership (Manager, Sr Manager and Director level)
•    High degree of initiative
•    Experience submitting expense reports and being responsible for a purchase card
•    Advanced knowledge of word processing, spreadsheet, database and graphics presentation applications (Microsoft Office, Adobe Acrobat, Documentum, SmartSheets, SharePoint). 
•    Organizational skills, highly detail oriented, and effective project management skills. 
•    Flexible with changing priorities, self-motivated, strong work ethic, attention to detail, works well under pressure in a dynamic environment. Tactful, exercises independent judgment and discretion, professional presentation, advanced communications skills (written and oral), team player, basic business acumen. 
•    Understanding of UDI requirements
 

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. 

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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible