Senior Global Compliance Director - CQS 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

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in Engineering, Sciences or related fields required (or advanced degree with reduced experience)
Minimum of 15 years of relevant experience with external inspections (FDA, OUS notified bodies), product risk (assessing fielded products & making recall decisions) within a Medical Device or highly regulated Manufacturing / Operations environment (or 13 years with advanced degree)
10+ years of managerial experience
Must maintain a current and valid Passport, with availability to travel up to 20% annually
Permanent address evident on resume for consideration (on-site role at specified Medtronic North America sites)

Responsibilities

Lead centralized Internal Audit function enterprise-wide, including audits of all sites, entity QMS (OU and Manufacturing sites), and functional enterprise audits (excludes clinical and regional)
Lead Audit Inspection Readiness Assessment (AIRA) program for external inspection readiness across the enterprise, including strategy development in partnership with OU’s/Platforms (Risk Burndown, defensibility, prioritization), owning Heat Map for enterprise sites and OUs, high risk field issues/field corrective actions/for cause inspections, understanding industry insights, and regulator consultancy
Process Owner: Manage Compliance process (enterprise-wide procedures for Internal and External Audit)
Data management and insights: Connect internal audit data, external audit data, and industry intelligence for trends and continuous improvement potential
Serve as Individual Contributor on Critical/High risk Inspections
Preparation and analysis of Metrics for Global QMR (involving CEO), Board of Directors meetings, and External Sustainability Reporting; prep and communication of key data to CQO and Executive Leadership monthly
Advocacy Presence: MDSAP Working Group, AdvaMed, Products councils
Case For Quality Steering Committee member

Skills

Internal Audit

Compliance

Quality Management System

QMS

Global Audit

Regulatory Compliance

Audit Leadership

Enterprise Audit

Manufacturing Audit

Cross-functional Collaboration

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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