Indonesia Job Openings

Mindray

Regulatory Affairs Specialist

November 7, 2024

Requirements:
  • Bachelor’s or Master’s degree in any field. Majoring in automation engineering or biomedical engineering is preferable.
  • At least 3 years of experience as Regulatory Affairs. Work experience in medical device registration is preferable.
  • Advanced English speaking and writing skills.
  • Excellent communication skills, teamwork, and able to maintain good performance under pressure.
  • Domicile in Jakarta

Responsibilities:
  • Undertake medical device registration, import & local product (AKD & AKL).
  • Maintain active communication with related authorities (MOH, Bapeten & MOI).
  • Conduct analysis of related regulations, including but not limited to the implementation of technical standards, required documents, and administrative work.
  • Create, collect, and submit the registration dossier.
  • Solve registration problems, push forward the registration process, and secure favorable registration results.
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