SEEN

PT Dwigraha Medical

18 day(s) ago

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Regulatory Officer

Experience Staff

Full-Time

DKI Jakarta, Kota Jakarta Timur
Working Mode : WFO

Job Responsibilities

  • Manage the process of registration, renewal, and changes to medical device distribution permits (AKD/NIE)
  • Prepare and ensure completeness of registration documents and Product Information Documents (DIP)
  • Ensure all distributed products have valid distribution permits and regulatory documents
  • Monitor changes in medical device regulations and ensure company compliance with applicable provisions
  • Coordinate with principal, QA, PJT, and related teams in fulfilling regulatory documents
  • Support the fulfillment and maintenance of CDAKB and implementation of regulatory audits
  • Manage regulatory documentation and reporting through applicable systems

Job Requirements

  • Minimum D3/S1 in Pharmacy, Health, Biomedics, or related field
  • Experience in Regulatory Affairs for medical devices, particularly in distribution, is an added value
  • Understanding of medical device registration processes, AKD/NIE, DIP, and CDAKB
  • Meticulous, organized, and able to manage large volumes of documents
  • Good communication and coordination skills with internal teams and principal
  • Able to work independently and as part of a team

Required Skills

Spoken Skills

Written Skills