22 ago
|
Medtronic
|
Bogotá
Careers that change lives start here. Medtronic is a integral leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
As an Associate Regulatory Affairs Specialist, you will support regulatory activities for medical devices across LATAM and APAC. This role focuses on regulatory documentation management, submissions, compliance activities, and coordination with internal and external stakeholders to support product registrations and commercialization efforts. This is a remote role based in Bogotá, Colombia.
Responsibilities may include the following and other duties may be assigned:
· Coordinate and prepare documentation packages for regulatory submissions, audits, and inspections
· Compile documentation required for regulatory submissions, license renewals, and annual registrations
· Review, organize, upload, and maintain regulatory documentation across multiple document management systems
· Support responses to regulatory agency requests by collecting and submitting required information and documentation
· Partner with internal stakeholders, regulatory teams, consultants, and distributors to ensure timely completion of regulatory activities
· Monitor documentation status and support compliance with regulatory requirement
· Recommends changes related to labeling, manufacturing, marketing, and clinical protocols to support regulatory compliance
· Stay informed on regulatory procedures, requirements, and changes affecting the business
Required Knowledge and Experience:
· Bachelor's degree completed or in progress, preferably in Healthcare, Bioengineering, Biotechnology, Pharmacy, Quality, Marketing, Business
📌 Associate Regulatory Affairs Specialist (Bogotá)
🏢 Medtronic
📍 Bogotá