At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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 assisting in the preparation publication quality control and delivery of regulatory submissions as well as working with International Geography RA groups to complete product registrations notarization authentication and providing notification of changes. Submissions are produced with electronic publishing tools in compliance with internal and external document standards. Prepares submits tracks indexes and archives electronic submissions as well as related information including approvals amendments annual reports and FDA/Regulatory Agency communications. Additional duties include developing international device product registrations maintaining global product registrations and developing department processes and systems. This role primarily interfaces with regulatory affairs teams operating unit (OU) regulatory teams regulatory operations teams manager and director.

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

• Responsible for activities related to enterprise-wide regulatory management systems including systems coordination training developing and implementing plans and providing input to systems designs.

• Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.

• Prepares submits tracks indexes and archives electronic submissions including information amendments annual reports general correspondence adverse event reporting and promotional materials.

• Responsible for helping to develop and to manage international product registrations including working with the regulatory affairs team and OUS geography specialists to respond to requests for information.

• Supports and processing of International CFGs and CFSs and International Requests.

• Manages international product registrations including working with the regulatory team and OUS geography specialists to respond to requests for information.

• Basic understanding of global regulatory requirements and approach for researching detailed requirements.

• 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.

• Ensure submissions are formatted and produced with electronic publishing tools in compliance with document management standards.

• Support value stream payment processing.

Required Knowledge and Experience:

• Bachelors degree in sciences engineering or field related experience.

• Advanced level of English

• Ability to work in a hybrid environment in Bogota

• Intermediate knowledge of word processing spreadsheet database and graphics presentation applications (Microsoft Office Adobe Acrobat Documentum and SharePoint).

• Organizational skills highly detail oriented and effective project management skills.

• 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.

• Ability to work in matrix structured organization.

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 95000 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