MDR/Vigilance Specialist at Medtronic

Koto-ku, Tokyo, Japan

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

医療機器, NeuroscienceIndustries

Requirements

Bachelor's degree or above
Experience in quality assurance or quality management based on the Pharmaceutical and Medical Device Act (preferably in the medical device industry)
Communication/negotiation skills
Presentation skills
English reading/writing experience in practical work
Native-level Japanese
Computer skills: PowerPoint/Word/Excel
Office location: Shinagawa office (in-office frequency: about once a week)

Responsibilities

Audit response: Prepare for internal and external audits and handle responses on the audit day
Recall operations: Evaluate safety and effectiveness in recall cases; formulate internal recall plans in accordance with the manufacturer's recall plan; collaborate with relevant parties to execute operations
Trend analysis: Analyze trends in complaint reports for product groups
Customer response: Issue analysis reports
Respond to inquiries from manufacturing, repair, sales, and rental businesses and create responses/instructions
Collaborate with internal manufacturing, repair, sales, and rental operations

Skills

薬機法

品質保証

品質管理

ISO13485

QMS省令

トレンド分析

監査対応

回収対応

Excel

PowerPoint

Word

PowerAutomate

プロジェクト管理

英語読解

英語ライティング

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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