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

Medical Devices, HealthcareIndustries

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

Responsibilities

Complaint handling: Confirm complaint reports from customers regarding products, and collect additional information as needed
Administrative reporting: Evaluate complaints received domestically and internationally, and report to PMDA as necessary
Instructions for use (IFU) and attached document management: Revise attached documents in line with IFU revisions by overseas manufacturers or minor/partial changes by RA
Audit support: Prepare for and respond to internal and external audits
Trend analysis: Analyze trends in complaint reports by product group
PMDA report creation: Determine necessity of PMDA reporting for cases and perform administrative reporting
Attached document revisions: Confirm IFU revisions and perform revisions; consult PMDA in advance for changes from RA and revise documents

Skills

Key technologies and capabilities for this role

薬機法PMDA reporting品質保証品質管理ISO13485QMS省令トレンド分析ExcelPowerPointWord英語読解英語ライティングコミュニケーションプレゼンテーションプロジェクト管理

Questions & Answers

Common questions about this position

What compensation and benefits does Medtronic offer for this role?

Medtronic offers a competitive salary and flexible benefits package. This position is eligible for the Medtronic Incentive Plan (MIP), a short-term incentive.

Is this position remote or does it require office work?

This information is not specified in the job description.

What are the must-have skills and experience for the MDR/Vigilance Specialist role?

Candidates must have a bachelor's degree or higher, experience in quality assurance or quality management under the Pharmaceutical and Medical Device Act (preferably in the medical device industry), communication/negotiation skills, presentation skills, business English reading/writing experience, native-level Japanese, and proficiency in PowerPoint/Word/Excel.

What is the company culture like at Medtronic?

Medtronic fosters a culture of exploration, innovation, and purpose-driven work to champion healthcare access and equity. The company values employee contributions, shares in their success, and unites a global team of over 95,000 passionate people focused on engineering solutions to health challenges.

What makes a strong candidate for this MDR/Vigilance Specialist position?

Strong candidates will have quality assurance or management experience under the Pharmaceutical and Medical Device Act in the medical device industry, along with knowledge of regulations like the QMS Ministerial Ordinance and ISO13485, project management skills, and intermediate Excel skills for trend analysis.

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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