Regulatory Operations Spec. at Medtronic

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

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in sciences, engineering, or field related experience
Advanced level of English
Ability to work in a hybrid environment in Bogota
Intermediate knowledge of word processing, spreadsheet, database and graphics presentation applications (Microsoft Office, Adobe Acrobat, Documentum, and SharePoint)
Organizational skills, highly detail oriented, and effective project management skills
Highly detail oriented and possess strong analytical skills to evaluate complex technical information
Document interpretation, queries and workflow skills
Flexible with changing priorities and works well under pressure in a fast paced, dynamic environment
Self-motivated, strategic thinker, team player, strong work ethic, tactful, exercises independent judgment and sound decision-making
Ability to work in matrix structured organization
Basic understanding of global regulatory requirements and approach for researching detailed requirements

Responsibilities

Assisting in the preparation, publication, quality control and delivery of regulatory submissions
Working with International Geography RA groups to complete product registrations, notarization, authentication and providing notification of changes
Preparing, submitting, tracking, indexing and archiving electronic submissions, as well as related information including approvals, amendments, annual reports, and FDA/Regulatory Agency communications
Developing international device product registrations and maintaining global product registrations
Developing department processes and systems
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training, developing and implementing plans, and providing input to systems designs
Ensuring continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors
Preparing, submitting, tracking, indexing and archiving electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials
Helping to develop and manage international product registrations, including working with the regulatory affairs team and OUS geography specialists to respond to requests for information
Supporting and processing of International CFG’s and CFS’s and International Requests
Managing international product registrations, including working with the regulatory team and OUS geography specialists to respond to requests for information
Participating in lean sigma/A3 DMAIC projects within the department to improve processes, including identifying and implementing metrics to enhance business efficiencies
Ensuring submissions are formatted and produced with electronic publishing tools in compliance with document management standards
Supporting value stream payment processing

Skills

Regulatory Submissions

Electronic Publishing

Product Registrations

Regulatory Affairs

Quality Control

FDA Compliance

Document Management

Process Improvement

Vendor Management

Regulatory Systems

Notarization

Authentication

Adverse Event Reporting

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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