Sr Regulatory Affairs Spec at Medtronic

North Haven, Connecticut, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Maintain proficiency in US and EU regulatory requirements
Establish and maintain good relationships with agency personnel
Ensure personal understanding of all quality policy/system items that are personally applicable
Follow all work/quality procedures to ensure quality system compliance and high-quality work
Comply with applicable US, EU, and international regulatory laws/regulations/standards and the Code of Conduct
Keep abreast of regulatory procedures and changes

Responsibilities

Plan and execute global regulatory activities for obtaining/maintaining regulatory clearance/certification in the US and Europe for powered surgical devices
Perform sustaining activities, including review of all change control activities related to assigned product family and performing regulatory assessments
Handle LTF, 510(k)s, technical documentation updates, and EU change notices resulting from regulatory assessments
Conduct labeling and ad promo review for assigned product family
Partner with international regulatory affairs group to support global submissions and registrations
Support currently marketed products by evaluating product changes and labeling changes, reviewing ad promo, and submitting change notifications to regulatory authorities
Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for changes to existing products
Work with RAS, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies
Prepare FDA submissions and European Technical Files/Technical Documentation (MDD and MDR) for product changes and/or new products to ensure timely product launch
Prepare submissions and reports for FDA and notified bodies, and support other international agencies as required
Interact directly with FDA and notified bodies, and indirectly with international regulatory agencies (significant issues reviewed with manager)
Support post-market regulatory compliance activities for US and EU
Develop and maintain regulatory affairs department procedures and implement process improvements
Assist in keeping the company informed of US and EU regulatory requirements
Direct or perform coordination and preparation of document packages for internal audits and inspections
Lead or compile all materials required for submissions, license renewals, and annual registrations
Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections

Skills

Regulatory Affairs

510(k)

EU MDR

Change Control

Technical Documentation

Labeling Review

Ad Promo Review

Global Regulatory Submissions

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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