Integra LifeSciences

Sr. Regulatory Affairs Specialist - Japan

Vacancy ID
2017-23842
JP-Tokyo
Position Type
Regular Full-Time
Category
Regulatory Affairs

Overview

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

 

Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery.  In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.


Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

Reporting to the RA/QA Manager, the Sr. Regulatory Affairs Associate will be responsible for Integra's Product Regulatory Registrations in Japan.

 

Key Duties and Responsibilities

  • Product Registration
  • Support Japanese distributors and RA consultant company for their preparing Shonin Application / Partial Change Application / Class 1 Notification
  • Prepare Shonin Application / Partial Change Application / Class 1 Notification
  • Support Japanese distributors for their preparing QMS Application
  • Manage Shonin documents registered in Japan
  • Interact with Japanese authorities and Medical Industry Groups
  • Manage reimbursement
  • Support QMS Application for Japanese distributor
  • Support QA section for FMR

Qualifications

Education and Experience

  • Minimum level of education needed to perform duties
  • Minimum 5-8 year RA experience in Pharmaceutical / Medical Device (Class IV) Industries

 

Essential Skills and Abilities

  • Excellent verbal and written communication skills
  • Ability to multiple tasks, prioritize and work under pressure
  • Strong negotiation skills with Japanese authorities (MHLW, PMDA, TMG, Notified body)
  • Good organization skills and ability

 

Competencies

  • Business level English
  • Computer skills – MS-Word, Excel, PowerPoint

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