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เกี่ยวกับตำแหน่งนี้

The Regulatory Affairs Medical Device Manufacturing position involves assisting companies in the registration and application of medical device products, participating in product registration plans, and establishing cooperative relationships with government departments and testing institutions.

หน้าที่รับผิดชอบ

• Assist companies in the registration and application of medical device products (including registration checks, registration applications, etc.).
• Participate in the company's product registration plan; writes, organizes, and submits enrollment application materials, tracks the enrollment process, and ensures certificates are obtained on time.
• Assist leaders in communicating with clinical trial agencies and registration and testing departments, as well as tracking and promoting project progress.
• Establish good cooperative relationships with government departments and testing institutions.
• Other responsibilities as needed.

คุณสมบัติ

• Bachelor's degree or higher in clinical medicine, biology, biotechnology, pharmacy and related majors.
• Conversational proficiency in English or above.
• More than three year of experience in the application product registration certificate (example: IPAK).
• Able to assist in completing the writing of product registration standards, and communicate effectively and well with government testing centers and review centers.
• Master the workflow and standards related to medical device product registration and quality system certification in Indonesia.