Regulatory Affairs Project Specialist at Medtronic

Lafayette, Colorado, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor's degree required
Minimum of 2 years of relevant experience, or a Master's degree with a minimum of 0 years relevant experience
Nice to Have: Experience with regulatory change assessments and filings for medical devices
Nice to Have: Project management experience
Nice to Have: Detail-oriented with strong organizational skills
Nice to Have: Knowledge of document control systems and regulatory submission tools

Responsibilities

Directs and coordinates the preparation of document packages for regulatory submissions, internal audits, and inspections
Leads or compiles all required materials for submissions, license renewals, and annual registrations
Assesses proposed changes to products, processes, or labeling to determine regulatory impact
Monitors and improves tracking systems for regulatory projects
Stays current with regulatory procedures and changes in relevant markets
Leads cross-functional teams (R&D, Quality, Manufacturing, Clinical) to gather information needed for change assessments and regulatory filings
Coordinates and prepares regulatory filings for submission to global health authorities, including FDA and Notified Bodies
Maintains accurate and up-to-date regulatory documentation for all sustaining activities
Monitors regulatory requirements and guidance to ensure ongoing compliance for relevant markets
Supports audits and inspections related to sustaining regulatory activities
Provides regulatory input and guidance throughout the product lifecycle

Skills

Regulatory Affairs

FDA submissions

Regulatory filings

Product compliance

Change assessments

Global regulations

Document preparation

Cross-functional leadership

Regulatory tracking

License renewals

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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