Sr Regulatory Affairs Specialist - Neuro 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, Neurovascular, HealthcareIndustries

Requirements

Bachelor's degree in Science or Engineering (or related field) from an accredited college or university
Minimum of 4 years of experience in medical device regulatory affairs, or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs

Responsibilities

Sustain the current product portfolio by ensuring compliance with US and EU regulatory requirements
Partner with the international regulatory affairs group to support regulatory submissions
Review changes to ensure regulatory requirements continue to be met, document “no file” decisions, review promotional materials, submit product changes and annual reports, and ensure product technical documentation is current and accurate
Provide strategic input and technical guidance on regulatory requirements for product modifications
Prepare Pre-Sub, IDE/IDE Supplement, PMA/PMA Supplement, 510(k) submissions and technical documents to support CE mark/MDR submissions
Manage multiple projects and prioritize tasks to meet project schedules
Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
Communicate with regulatory agencies and Notified Body and serve as regulatory liaison on the project team throughout the product lifecycle
Review promotional and advertising material
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
Participate in internal and external audits as needed
Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements
Perform other duties as assigned or required

Skills

Regulatory Affairs

US FDA Regulations

EU MDR

Regulatory Submissions

Product Compliance

Promotional Materials Review

Technical Documentation

Annual Reports

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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