Integra LifeSciences

GVP / Safety Manager Manager - Japan

Vacancy ID
2017-23841
JP-Tokyo
Position Type
Regular Full-Time
Category
Quality Assurance

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

Reportng to the RA/QA Manager, this position will be responsible for creating procedures for vigilance (and QA/ISO 13485 certification) and will be responsible for the gathtering of Codman complaints/adverse events.

 

Key Duties and Responsibilities

  • Quality System Management
  • Prepare/revise/control SOPs and forms to ensure compliance with Japan QMS requirements.
  • Cooperate with QA Manager
  • Gain and maintain ISO13485 certificate.
  • GVP Tasks and Product Complaint Handling
  • Manage GVP tasks regulated in GVP requirements
  • Manage product complaint handling
  • Communicate with responsible person in medical institute with regard to product complaint
  • Create and revise Package Insert (J-IFU)
  • Notice and communicate with PMDA for Package Insert

Qualifications

Qualifications

  • GVP Manager regulated in PMD Act

 

Education and Experience

  • Minimum level of education needed to perform duties
  • Minimum 5-8 year GVP 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 Japan 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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