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Medtronic

Medical device maker advancing therapies

Regulatory Affairs Specialist

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

About the Job

Requirements

  • At least 3 years of experience as a regulatory affairs submissions specialist.
  • Have handled at least 10 medical device manufacturing and marketing approval minor change notifications (including certification-related changes) or change notifications.
  • Have handled at least 5 new medical device manufacturing and marketing notification filings.
  • Have handled at least 3 partial-change approval applications for medical device manufacturing and marketing approvals (including certification-related changes, excluding expedited manufacturing-site changes).
  • Have handled at least 1 new medical device manufacturing and marketing approval application, regardless of class.
  • Have handled insurance coverage applications in category A or B.
  • Have general knowledge required of a regulatory affairs submissions specialist.
  • Have English proficiency equivalent to TOEIC 650 or higher, or Eiken Grade 2 or higher.
  • Be able to aggregate and manage data in Excel using functions, filters, and pivot tables.
  • Be able to create documents in Word.
  • Be able to create presentation materials and edit presentation slides in PowerPoint.
  • Be able to operate online meetings and collaborate using Teams.
  • Be able to communicate in English, including general communication with the design center and reviewing application documents in English.
  • Be able to accurately understand regulatory information, product information, and approval information.
  • Be able to appropriately understand others' intentions.
  • Be able to manage data using internal systems.
  • Be able to collaborate with stakeholders.
  • Be able to manage multiple projects in parallel.
  • Hold at least a bachelor's degree in a science-related field.

Responsibilities

  • Handle regulatory affairs work for the introduction, maintenance, and lifecycle management of spinal medical devices and biomaterial products in Japan.
  • Submit approval applications, certification applications, and notifications for new products.
  • Maintain existing approved products through partial-change applications and minor-change notifications.
  • Conduct face-to-face consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) regarding regulatory strategies for new products.
  • Assess regulatory impacts of product changes and formulate regulatory response policies.
  • Coordinate regulatory matters and gather information with overseas manufacturers.
  • Prepare package inserts, electronic package inserts, and other regulatory documents.
  • Research laws, regulations, notices, and industry trends, and share findings internally.
  • Register and maintain data in internal systems.

Desired Qualifications

  • Experience with new medical device manufacturing and marketing approval applications for Class III or higher devices.
  • Experience with face-to-face consultations, such as pre-development consultations.
  • Experience with insurance coverage applications in category C.

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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