Director, Regulatory Compliance - Diabetes at Medtronic

Los Angeles, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Diabetes CareIndustries

Requirements

Candidates must possess a Bachelor's degree with over 10 years of experience, including 7 years in leadership, or an Advanced degree with over 8 years of experience, including 7 years in leadership. Proven experience in developing and implementing global regulatory strategies and strong knowledge of regulatory requirements are essential.

Responsibilities

The Director of Regulatory Compliance will provide strategic leadership for end-to-end regulatory compliance and process efficiency within the Regulatory Science & Communications (RSC) organization. This role involves developing and implementing global regulatory strategies, monitoring regulatory changes, managing a team of professionals, overseeing vendor relationships, and ensuring compliance with global regulatory requirements such as FDA, ISO, and EU MDR. Responsibilities also include leading the review of advertising and promotional materials, driving continuous improvement in regulatory operations, participating in leadership team decisions, and managing the departmental budget.

Skills

Regulatory Compliance

Regulatory Affairs

Regulatory Strategy

Global Regulatory Requirements

FDA

ISO

EU MDR

Process Efficiency

Cross-functional Alignment

Leadership

Team Management

Operational Excellence

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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