Senior Regulatory Specialist Coordinator, Advertising and Promotion at Medtronic

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in science, communication, or a healthcare-related field
4 years of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling, or an advanced degree with 2 years’ experience

Responsibilities

Support review of advertising and promotional material to ensure that it meets all medical, legal, and regulatory (MLR) process requirements
Facilitate online and offline review meetings with authors, reviewers/approvers to ensure content approval that supports business needs
Act as SME for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements
Support the preparation of US and International promotional labeling material, including the creation of a claims matrix database and claims objects
Lead AI/ML adoption in content and claims management to support automation and enhance process efficiency
Drive the pending review/approval requests for Ad Promo, and work with reviewers to push the approvals in a timely fashion
Create reports & metrics to provide visibility to management on cycle times of review/approval
Process improvement: work with a cross-functional team to map the process, identify bottlenecks, provide solutions, and author new process documents
Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct
Provide training support for new authors, asset owners, and reviewers/approvers
Facilitate review/approval system changes and user support

Skills

Regulatory Compliance

Advertising Review

MLR Process

FDA Regulations

Process Improvement

Claims Matrix

AI/ML

Content Management

Cross-Functional Collaboration

Metrics Reporting

Training Delivery

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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