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Regulatory Affair Officer

PT Oneject Indonesia Cikarang Pusat, Jawa Barat

Deskripsi pekerjaan

Calling for all experienced candidates in regulatory affair to be placed in Cikarang area

Kualifikasi: Minimum Bachelor degree (S1) from majoring in Pharmacy /Biomedical Engineering / Biotechnology / Biology / Public Health / Apothecary Profession / any major related; Having minimum 1 years of working experience as Regulatory Affair preferably in the medical device industry; Familiar with Indonesian medical device regulations and product registration processes.; Experienced with all activities related to regulation and compliance product are align with updated regulation, local registrations (KEMENKES/LPPOM MUI/KEMENPERIN.), Experience in handling Technical Documentation or regulatory submissions for global; Good command of English, both written and verbal; Proficient in Microsoft Office (Excel, Word, PowerPoint); Strong analytical thinking, documentation, and project management skills; Able to work independently while coordinating effectively with cross-functional teams.; Willing to be placed in Cikarang area.

Kualifikasi

  • Minimum Bachelor degree (S1) from majoring in Pharmacy /Biomedical Engineering / Biotechnology / Biology / Public Health / Apothecary Profession / any major related
  • Having minimum 1 years of working experience as Regulatory Affair preferably in the medical device industry
  • Familiar with Indonesian medical device regulations and product registration processes.
  • Experienced with all activities related to regulation and compliance product are align with updated regulation, local registrations (KEMENKES/LPPOM MUI/KEMENPERIN.), Experience in handling Technical Documentation or regulatory submissions for global
  • Good command of English, both written and verbal
  • Proficient in Microsoft Office (Excel, Word, PowerPoint)
  • Strong analytical thinking, documentation, and project management skills
  • Able to work independently while coordinating effectively with cross-functional teams.
  • Willing to be placed in Cikarang area

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Tipe pekerjaan
Full-time
Gaji
Negosiasi

Cara melamar

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