Regulatory Affairs Specialist at Medtronic

Bogota, D.C., Bogota, D.C., Colombia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or related field
Minimum 2 years of experience in regulatory affairs
Advanced proficiency in Spanish and English (reading, writing, speaking)
Fluent in English; Portuguese proficiency preferred
Experience in medical devices or pharmaceutical industry
Strong understanding of LATAM regulatory environments and market dynamics
Ability to work in a matrix-structured organization
High proficiency in Microsoft Office tools and database management
Excellent communication and presentation skills
Strong analytical, problem-solving, and decision-making abilities
Ability to manage multiple projects and meet deadlines
Team-oriented with a proactive and strategic mindset
Candidates must reside in Colombia

Responsibilities

Create and follow up on insight applications, events, and tasks
Clarify regulatory questions from Business Units (BU)
Complete local registration applications and design monographs for Brazilian submissions
Draft technical reports and monographs that support registration history
Manage and distribute legal documents (CFGs, FSCs, ISOs)
Oversee translation management for assigned clusters
Build and validate dossiers for all LATAM countries, including double-checks for Mexican submissions
Coordinate submission planning with Business Partners and Operating Units
Respond to government inquiries and support RAN management under RA Manager guidance
Notify stakeholders of approvals across sOU, international, regional, and local teams
Verify and validate data for publication in regulatory databases
Collaborate with Sr. RAS, Associate RAS, and Project Coordinators
Train regulatory teams on LATAM regulations and workflows
Attend internal and external regulatory training sessions
Provide data for statistical reports and support budget tasks for LATAM countries
Assist Regulatory Operations with RAC assessments, blocked orders, and batch releases
Support audits, importations, tenders, and inventory deployment as needed
Stay current on regulatory legislation and guidelines
Maximize team efficiency by executing strategies that impact the broader RA function (e.g., master dossiers)
Maintain tracking tools (Excel, Smartsheet) for regulatory process advancement
Provide backup support to fellow RAS team members
Actively participate in strategic reviews and SSC projects with international teams

Skills

Regulatory Affairs

LATAM Regulations

Registration Applications

Dossier Management

Technical Reports

Translation Management

Submission Planning

Compliance

Cross-functional Collaboration

Regulatory Databases

RAN Management

ISO Standards

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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