Job Title: Regulatory Affairs Specialist
Location: Hybrid, Bogotá, Colombia
Time Type: Full Time
Posted On: 5 Days Ago
End Date to Apply: May 19, 2025
Job Requisition ID: R27805
Job Description
At Medtronic, you can begin a lifelong career of exploration and innovation while championing healthcare access and equity for all. Join us in leading with purpose and breaking down barriers to innovation in a more connected and compassionate world.
A Day in the Life
As a Regulatory Affairs Specialist, you will be responsible for coordinating and preparing document packages for regulatory submissions. You will also support internal audits, ensure compliance, and maintain up-to-date knowledge of regulatory procedures and requirements. This hybrid role is based in Bogotá, Colombia.
Key Responsibilities
Coordinate and prepare regulatory submission documents from all areas of the company, including support for internal audits and inspections.
Lead the compilation of materials for submissions, license renewals, and annual registrations.
Recommend necessary changes in labeling, manufacturing, marketing, and clinical protocols for regulatory compliance.
Monitor and improve tracking and control systems.
Stay current with changing regulatory procedures and policies.
Interact directly with regulatory agencies on defined matters.
Recommend strategies for the earliest possible approvals of clinical trial applications.
Required Qualifications
Bachelor’s degree in a relevant field.
Minimum of 2 years of experience in regulatory affairs or regulatory operations.
Fluent in English.
Proficiency in Microsoft Office Suite (Outlook, Excel, Word, PowerPoint).
Growth-oriented with a global mindset.
Capable of working in a matrix-structured organization.
Experience with SAP and GTS is an advantage.
About Medtronic
Medtronic is one of the world’s largest medical technology companies, transforming healthcare through innovation and collaboration. Our mission is to alleviate pain, restore health, and extend life, impacting more than 75 million lives annually. With over 95,000 dedicated professionals globally, we are engineers at heart—driven by bold ideas and grounded in real-world impact.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. We value our employees' contributions and offer a broad range of resources and compensation plans to support you at every stage of your career and life.
Gujarat :
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