Assoc Regulatory Affairs Spec-11.

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 95000 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.

Were a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality affordable healthcare worldwide.



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:

Bachelors 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).