Job Description
<Job Responsibilities> - Lead product registration, compliance updates, and regulatory changes. - Serve as the main point of contact for technical communication with MOH. - Prepare and review regulatory documents and compliance submissions. - Provide internal guidance on regulatory standards and technical compliance. - Other responsibilities as needed
Job Requirement
<Necessary Skill / Experience > ・Bachelor's degree or higher in clinical medicine, biology, biotechnology, pharmacy and related majors. ・Business English proficiency. ・Minimum of 3 years of experience in Medical Equipment industry as Technical Manager with experience in product registration, regulatory compliance, and product change management. ・Valid STR-A or STR-TEM license and ability to communicate effectively with the Indonesian Ministry of Health (MoH). ・Good communication skill, good work ethics, able to multitask <Preferable Skill / Experience> ・Mandarin conversation level or above ・Experienced working in Japanese or Chinese medical device company