Regulatory Affair Officer

Qualifications

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 market, Experience using government submission systems (SERALKES, OSS, etc.), supporting end-to-end product registration and regulatory compliance in the medical device industry

• 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