REGULATORY MANAGER / Asst Manager – medical device manufacturer
JPC TEXSON LTDChinaUpdate time: May 29,2020
Job Description
THE COMPANY :
  • Manufacturer of medical device, surgical device & instruments with office in Hong Kong and factory in Dongguan China
  • Mainly export to North America and European markets
  • Core items are precision electro-surgical pencil, surgical knife, surgical sealer, wound dressing, skin stapler, cardiac insulation pad, oxygen filter etc
  • We are looking for REGULATORY MANAGER – with details as follows :
 
THE JOB :
  • Handle regulatory affairs, such as product license registration/renewal, coordinating customers/internal audits, preparing of ISO documentations and etc.
  • Maintain the COPs in comply with ISO 13485.
  • Maintain good relationship with certify bodies
  • Conduct and organize seminar or training: for staffs to fulfill the regulatory requirements.
  • Degree holder
  • Studies in Bio-medical Engineering, Legal Studies or related disciplines is a plus
  • At least 5 year solid experience in medical devices industry.
  • Good knowledge in ISO 13485, ISO9001, 510K, CE, CMDCAS, CFDA legislation.
  • A team player and detail minded
  • Good command of English and Mandarin
  • Station Dongguan
  • Company shuttle bus transportation provided
  • Accommodations and meals provided
  • Annual leave : 14 days
  • Medical benefits
  • Less experience will be considered as Regulatory Asst Manager
 
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