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Medtronic

Medical device maker advancing therapies

Senior Technical Solutions Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeTokyo, Japan

About the Job

Requirements

  • Experience driving cases across multiple departments.
  • Knowledge of 3D mapping systems, including Affera, and EP and ablation.
  • High-level Japanese communication and writing skills.
  • Practical English proficiency for email, meetings, and document handling with global teams.
  • Practical skills using Microsoft Office, including Excel.
  • Project management and coordination skills to manage multiple cases concurrently, prioritize, and drive progress.
  • Bachelor's degree or higher; any major is acceptable.

Responsibilities

  • Collect, organize, review, and document information about product defects reported in the market.
  • Assess the nature, scope, and urgency of defects, prioritize them, and coordinate with relevant departments to drive appropriate initial responses.
  • Gather information needed to respond to defects in a timely manner and share it appropriately with internal stakeholders.
  • Continuously manage case progress, issues, and unresolved matters, and escalate when necessary.
  • Coordinate with Global Technical Service, Quality, Operations, and other related teams to collect response plans and required information regarding product defects.
  • Work with domestic Sales, Marketing, T&E, Quality Assurance, and other related departments to advance case responses.
  • Accurately and promptly share global updates and instructions with local stakeholders.
  • Set up meetings, organize discussion points, and manage actions as needed to support cross-functional execution.
  • Execute product-defect response operations accurately and within deadlines.
  • Maintain smooth information sharing among global and domestic stakeholders to advance case handling.
  • Maintain operations that meet quality and compliance requirements.
  • Take initiative on complex cases by organizing issues and engaging stakeholders to resolve them.
  • Monitor product use and analyze inquiries and errors to identify early signals of potential quality problems before they become issues requiring Quality Assurance operations.

Desired Qualifications

  • Clinical experience with 3D mapping systems, including Affera, and EP and ablation.
  • Experience in related areas such as Quality, Technical Service, or complaint handling.
  • Experience handling market product defects, complaint processing, quality assurance, regulatory affairs, or FCA operations in the medical-device industry.
  • Experience working in a global matrix organization.
  • Experience creating standard operating procedures, improving operations, or delivering training.
  • Bachelor's or master's degree in an engineering discipline.

About the Company

Medtronic

Medical device maker advancing therapies

Medtronic develops medical devices that diagnose, monitor, and treat chronic diseases. Its products include implantables, sensors, and therapies used in cardiovascular care, diabetes management, and neurostimulation, working by interacting with the body to regulate or monitor physiological processes. The company differentiates itself through a long history of device development, strategic acquisitions like Covidien, and a broad, diversified portfolio across therapeutic areas. Its goal is to improve patients’ health outcomes by delivering integrated medical technologies and solutions for disease management.

Company size
10,001+
Company stage
IPO
Headquarters
Fridley, MN
Founded
1949

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