Associate Regulatory Affairs Specialist

Associate Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global 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.

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 Administration, or related fields
• 1-2 years of professional experience in Regulatory Affairs, Quality, Compliance, Documentation Management, Customer Service, Supply Chain, Legal, Administrative, or other related operational functions is preferred
• Experience supporting documentation-intensive processes, submissions, registrations, compliance activities, or stakeholder management is desirable
• Fluent English required; ability to communicate effectively in a professional environment as interviews and stakeholder interactions may be conducted in English
• Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint
• Strong organizational skills with the ability to manage multiple priorities, deadlines, and documentation requirements simultaneously
• Ability to work independently in a remote environment while collaborating effectively with internal and external stakeholders
• Experience working in regulated industries such as medical devices, pharmaceuticals, healthcare, or related fields is preferred

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.

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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).