Title:  Regulatory Affairs Specialist

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.
• Advanced English speaking and writing skills.
•  Excellent communication skills, teamwork, and able to maintain good performance under pressure.
• Work experience in medical device registration is preferable.
• Domicile in Jakarta
   

Responsibilities:

• Undertake medical device registration.
• 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.
• Maintain active communication with consultants and related authorities.
• Solve registration problems, push forward the registration process, and secure favorable registration results.