Job Description
Full details about the role and requirements
Yukerja Summary
The Regulatory Affair Officer role at Oneject is curated from JobStreet (category Teknologi & IT). Note the work location (Cikarang Pusat, West Java) before applying. Yukerja.com is not the employer — applications are handled on the official source site.
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