Sr. Regulatory Affairs Specialist at Medtronic

Lafayette, Colorado, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
(Nice to Have) Experience in the medical device industry
(Nice to Have) Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)
(Nice to Have) Excellent attention to details, proactive approach and ability to work independently
(Nice to Have) High learning agility and ability to work under pressure
(Nice to Have) Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines

Responsibilities

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
Leads or compiles all materials required in submissions, license renewal and annual registrations
Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities including design changes
Write, update and maintain technical documentation
Review promotional material for accuracy and compliance
Keeps abreast of regulatory procedures and changes
May direct interaction with regulatory agencies on defined matters
Recommends strategies for earliest possible approvals of clinical trials applications

Skills

Regulatory Compliance

Regulatory Submissions

Medical Devices

Technical Documentation

Post-Market Surveillance

Global Regulatory Frameworks

Internal Audits

Inspections

Promotional Material Review

Clinical Trials Applications

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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