Principal Labeling Specialist at Medtronic

Minneapolis, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, NeuroscienceIndustries

Requirements

Expertise in medical device labeling for Neuroscience portfolio products
Knowledge of regulatory and quality standards (e.g., FDA, EU MDR, ISO)
Ability to manage and execute labeling tasks and deliverables for R&D projects, new product development, sustaining activities, and compliance-driven initiatives
Accountability for labeling content and supporting documentation (e.g., design plans, design input requirements, tracing documents, review documentation, verification reports)
Capability to support investigation, documentation, and resolution of labeling-related quality issues

Responsibilities

Supports the Neuroscience labeling team in developing and executing project timelines for programs impacting labeling content creation or updates
Collaborates with departmental and cross-functional peers to resolve labeling-related issues during development
Creates and reviews text required for labeling medical products
Ensures compliance of labeling with all applicable regulatory/QSR requirements
Monitors, evaluates, and recommends improvements to labeling processes, quality, systems tools, and/or policies
Continually reviews the document development process to ensure quality in labeling output
Manages all aspects of document development and assists in production release, including draft reviews, formal labeling approvals, coordination of translations, and initiating CO/CA release
Revises, edits, and formats legacy product documentation (e.g., user’s guides, service manuals, IFPs, IFUs)
Delivers supporting documentation for labeling products (e.g., labeling design plans, trace documents, technical reviews)
Produces customer-facing product documentation (e.g., user guides, service manuals, IFUs) for clinician and patient labeling

Skills

Medical Device Labeling

Product Documentation

User Guides

Service Manuals

Instructions for Use

IFU

Neuromodulation

Regulatory Compliance

Technical Writing

Project Management

Neuroscience

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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