Johnson & Johnson Careers

[Medical Devices] RA Specialist (1 Year Contractor)

Taiwan; Taipei, Taiwan
Regulatory Affairs


Job Description

Requisition ID: 00001CAT

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
 
 
1. Position Title: RA Specialist
2. Sector: Medical Devices
3. Location: Taipei, Taiwan
4. Employment Type : One Year Contract
 
 
[Key Roles & Responsibilities]
 
  • Ensure compliance to local regulations and  J&J policies
  • Implement NPI & develop the regulatory submission plan
  • Oversee the preparation and review registration documents to ensure the submission meet appropriate standard and content requirement
  • Interact with regulatory agency actively to expedite approval of pending application and to resolve regulatory matters
  • Account for relationship and communication with Regulatory Authorities, as well as business units and sourcing affiliates
  • Guide the archiving of all regulatory documents  & ensure the safe storage & accessibility
  • Maintain up-to-date knowledge of local regulation & J&J policies
  • Provide regulatory affairs support during internal & external audit
  • Coach and give guidance to junior level RA colleagues
  • Other projects assigned by line manager
     
 

Qualifications
[Job Requirements/Qualifications]
 
  • Field of Study : Life Science, Medical Technology , Engineering , Business Management,
  • Education Level : University Degree or above
  • At least 2 years’ experience in managing RA business in Medical Device or Pharmaceutical Industry


Primary Location
Taiwan--
Other Locations
Asia Pacific-Taiwan-Taipei-Taipei
Organization
Johnson & Johnson Medical Taiwan Ltd. (8582)
Job Function
Regulatory Affairs
Requisition ID
00001CAT