Integra LifeSciences

Supervisor, Regulatory Affairs - China

Vacancy ID
2017-23840
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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

The RA supervisor, is responsible for product registration including testing, submissions dossier preparation and follow Technical Evaluation also other regulatory process in China.The RA supervisor should be familiar with China Medical Device regulation especially Active device, also possess good knowledge internationally including European Medical Device Directives, FDA regulation. This position directly report to Manager, Quality Assurance & Regulatory Affairs, Intl.

 

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

 

Regulatory assessment for registration projects.

  • Overall responsibility and comprehensive insight into Neurosurgical products registration in charged.
  • Independently work with International and division RA team and stakeholders to initiate local product registration.
  • Capable for take care multiple complex registration projects.  
  • In-depth knowledge of IEC/EMC testing and good experience for Active Device registration.
  • Experience of China CER will be preferred.
  • Electrical Engineering background will be preferred.  
  • Basic knowledge of quality system.
  • Good communication with CFDA and Testing Labs. 
  • Regulatory intelligence and Analysis: there are many new regulations which will be interpreted timely.
  • Regulatory assessment for design input and changed when needed.
  • Accurately completes administrative activities in a timely manner.
  • Establish good communication within RAQA and other functions primarily at project level.
  • Performs other duties as line manager required.
  • Ability to travel 25% of time.

 

Qualifications

Qualifications:

 

  • BS or BA degree is preferred.
  • 3+ years of experience in Active Medical Device regulatory.
  • With neurosurgical products registration experience will be preferred.
  • With international enterprise experience will be preferred.
  • Familiar with CFDA related regulation will be required.
  • Familiar with CER will be preferred.
  • Good oral English will be required.
  • Good paper work and office software.
  • Good communication skill.
  • Strong team work spirit both in local and in headquarter functions 


Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed