PJT & REGULATORY AFFAIRS

Responsibilities Responsible for the technical aspects of medical devices

Ensure compliance with medical device regulations & licensing

Supervise installation, function testing, calibration & maintenance.

Handle technical complaints & corrective/preventive actions.

Draft & review technical documents (SOPs, manuals, reports).

Act as the technical PIC for audits, inspections, & licensing.

Provide technical support & training.

Qualifications

Educational background:

Diploma (D3) or Bachelor's Degree (S1) in Pharmacy or Pharmacist Professional Degree

Bachelor's Degree (S1) in Biomedical Engineering

Diploma (D3)/Bachelor's Degree (S1) in Informatics Engineering (specifically for medical device software). Preferred

Minimum 1-2 years of experience in the medical device field.

Possess a Good Distribution Practice (GDP/CDB) training certificate for Medical Devices for Technical Persons in Charge from the Ministry of Health.

Understand regulations, IDAK, and the CDAKB (Good Distribution Practice for Medical Devices) quality system.

Familiar with medical device standards such as ISO 13485, ISO 14971, and CSDT (Common Submission Dossier Template) documents for AKL (imported medical device) registration purposes at the Ministry of Health.

Have a solid understanding of software validation (IEC 62304) for SaMD/SiMD, or sterilization processes and biocompatibility for sterile non-electromedical devices.

Will be registered as a PJT in OSS/Ministry of Health (Kemenkes).

Detail‑oriented, responsible, & communicative.

PARTTIME ARE WELCOME

Bekasi, West Java, ID

Central Jakarta, Jakarta, ID

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