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Regulatory Affair Manager – PT Transmedic Indonesia

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PT Transmedic Indonesia from the start of their operation always commit ourselves to provide the best service for the wide range of advanced medical devices that we represent. Our dedication and service excellence are widely respected by nurses, doctors, and their respective organization. As part of regional network of companies, PT Transmedic Indonesia bring newly promoted, advanced medical technologies in a way that we become a bridge between new technologies and Indonesia medical world. We are committed to do our part not only as a sole distributor but also as a partner for the advancement of medical technologies in Indonesia.

Job Descriptions:
Responsibilities  
  •  Support all regulatory affairs and compliance related activities
  •  Prepare registration dossier for related agencies (MoH/BPOM, Depkes, Bapeten, etc)
  •  Communicate with principal, liaise with the team and related department to manage registration dossier including timely  applications
  • Maintain documents, database and prepare regular regulatory and compliance report (internally and externally)
  • Helping the department to interpret and implement all regulations applicable to company and ensure compliance
  •  Maintain strong relationship with all stakeholder
  Requirements :  
  •  Bachelor degree (Pharmacy is preferred)
  •  Minimum has 5 years of experiences as Regulatory Affair Officer
  •  Good personal and interpersonal skill 
  •  Having a good raport and experience in dealing with MOH/BPOM/Depkes/Bapeten will be an advantage
  •  Able to handle administrative duties and good documentation skill
  •   Preferably has experience in preparing reports requested by government agency
 

Tanggal Buka Lowongan : 17 January 2018 (Tutup pada 16-February-2018)
Gaji : Bisa hubungi PT Transmedic Indonesia - Jl. Senen Raya No. 135-137, Perkantoran Menara ERA Unit G-01 Jakarta Pusat 10410
Industri : Kesehatan/Medis


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