Integra LifeSciences

  • Project Manager, International Regulatory Operations

    Vacancy ID
    2018-27441
    Location
    CN-Shanghai-
    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 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

    Responsibilities

    Reporting to the Director, International Regulatory Operations this position will be accountable for leading cross functional team members to deliver international product registrations in countries with complex medical devices regulatory pathways (Japan, China, Brazil, Russia, Korea, etc). The PM, International Regulatory Operations will be responsible for interfacing with regulatory staff in country, R&D engineers, clinical representatives, and Quality staff to define project scope requirements, testing requirements, clinical requirements and to manage project deliverables, cost and timelines.

     

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

    •  Define registration project scope and requirements by liaising with cross-functional stakeholders in the RA, R&D, Clinical, and QA departments
    • Drive development of test method/protocols with R&D that meet in country standards
    • Manage shipment of samples for testing in country and liaise with R&D on in country testing issues/results
    • Resolve discrepancies and manage conflicts between competing input for registrations
    • Expert at project management methodologies and tools
    • Track and document project successes, failures, and lessons learned to continuously improve the project management function
    • Ensure regulatory compliance within assigned registration projects

    Qualifications

    • Bachelor’s degree in science, engineering or medical device science related discipline from an accredited university or college.
    • A minimum of 4 years of Project Management related experience in a highly regulated product development environment, operating within Design Control procedures, preferably from within the medical device industry.

     

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