Associate Regulatory Operations Specialist (Bogotá)

Associate Regulatory Operations Specialist (Bogotá)

13 ago
|
MDU Medtronic USA
|
Bogotá

13 ago

MDU Medtronic USA

Bogotá

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.

A Day in the Life

This position is part of the Regulatory Affairs Data and Product Release Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes. Primary responsibilities include supporting our Unique Device Identification (UDI) process and system to ensure general regulatory compliance and data integrity. Duties may include participating in projects supporting our Regulatory Affairs teams within the Operating Units and Regulatory Operations. This role primarily interfaces with regulatory affairs teams, operating unit (OU) regulatory teams, regulatory operations teams, manager and director. A role in MCRS offers unique experience opportunities, such as: being part of a global team, collaborating with business partners throughout the company, visibility to global structures and impacts, and insight to various processes and functions across Medtronic.

This role is a hybrid position based in Bogota.

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

- Activities related to enterprise-wide regulatory management systems,



including systems coordination, training, developing and implementing plans, and providing input to systems designs.
- Performs Regulatory Operations activities including data transformation to support global UDI submissions
- Collaborates with global regulatory affairs teams and operation units to gather and analyze required information
- Participates actively in cross-functional teams to meet timelines, resolve regulatory issues, and improve work processes.

Required Knowledge and Experience

- Bachelor’s degree required
- 6 months to 1 year of experience

- Advanced proficiency in English

- High learning agility
- Organizational skills and highly detail oriented
- Flexible with changing priorities, self-motivated, strong work ethic, works well under pressure in a dynamic environment
- Intermediate knowledge of spreadsheet and database applications (Microsoft Office, SharePoint, and Sitebuilder)
- Analytical and problem-solving skills
- Document interpretation, queries and workflow skills

- Excellent communication skills

Nice to Have

- Experience in medical device
- Experience with regulatory affairs or quality

- Experience with UDI
- Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)
- Advanced communications skills (written and oral)

- Effective project management skills

Physical Job Requirements ‌

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📌 Associate Regulatory Operations Specialist (Bogotá)
🏢 MDU Medtronic USA
📍 Bogotá

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