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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