Senior Regulatory Affairs Specialist- Structural Heart at Medtronic

Mounds View, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, Structural HeartIndustries

Requirements

Support worldwide regulatory activities for innovative transcatheter tricuspid valve therapy (Class III device)
Develop strategies for worldwide governmental approval of new products (Class II and Class III)
Provide advice on regulatory requirements
Prepare worldwide regulatory submissions and negotiate approvals with agencies
Assess device changes for regulatory implications and perform regulatory activities for implementation
Work onsite a minimum of 4 days per week in Mounds View, MN or Santa Rosa, CA
Ensure personal understanding of applicable quality policy/system items and follow all work/quality procedures for compliance

Responsibilities

Team with operating unit Regulatory Affairs Specialists and international regulatory staff to develop and execute regulatory strategies for new and existing products, aligning with business objectives and regulatory requirements
Collaborate with R&D, Quality, Clinical, and Marketing teams to ensure regulatory compliance throughout product development and resolve regulatory issues/questions from agencies
Prepare regulatory documentation for new products, product changes, audits, clinical studies, and market release; review significant submissions with manager and negotiate with agency personnel
Assist in negotiations with FDA and/or international regulatory agencies on assigned projects/products
Support regulatory compliance activities, including manufacturing site registration, audits, and annual reporting
Monitor and analyze regulatory trends/changes, providing strategic guidance to cross-functional teams
Provide business and product information to international regulatory staff to enable strategy development and communicate to business teams
Maintain regulatory documentation to ensure compliance

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory StrategyFDA SubmissionsPMA510(k)Class III DevicesClass II DevicesDevice Change AssessmentGlobal Regulatory ApprovalsTranscatheter Valve Therapy

Questions & Answers

Common questions about this position

Is this a remote position or does it require onsite work?

This is a hybrid role requiring a minimum of 4 days a week onsite to foster professional growth and cross-functional collaboration. The position is based in Mounds View, MN or Santa Rosa, CA.

What are the main responsibilities of the Senior Regulatory Affairs Specialist?

The role involves developing worldwide regulatory strategies for Class II and III products, preparing submissions, negotiating approvals, assessing device changes for regulatory impact, and collaborating with R&D, Quality, Clinical, and Marketing teams.

What is the company culture like at Medtronic?

Medtronic emphasizes bringing bold ideas forward with speed and decisiveness, putting patients first, and fostering a culture of professional growth and cross-functional collaboration through in-person exchanges.

What salary or compensation does this role offer?

This information is not specified in the job description.

What makes a strong candidate for this Senior Regulatory Affairs Specialist role?

Strong candidates will have expertise in regulatory strategies for Class II and III devices, experience with worldwide submissions and agency negotiations, and the ability to collaborate across R&D, Quality, Clinical, and Marketing teams on innovative projects like transcatheter tricuspid valve therapy.

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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