Integra LifeSciences RA Specialist in United States
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."
-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
-Support QMS Application for Japanese distributor
-Support QA section for FMR
Education and Experience
Minimum level of education needed to perform duties
Minimum 5 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
Business level English
Computer skills – MS-Word, Excel, PowerPoint
Vacancy ID 2018-26294
Position Type Regular Full-Time
Category Regulatory Affairs