Regulatory Affairs Officer

3 weeks ago

Mandaluyong, Philippines Aljeron Medical Full time

Regulatory Affairs Officer (Medical Device) Pasig, National Capital Region, Philippines 1 week ago Company : Aljeron Medical Enterprises, Inc. (AMEI) is a licensed servicer, importer, and distributor of various surgical, diagnostic, laboratory, and radiological equipment and devices. Headquartered in Metro Manila, AMEI operates nationwide through its sales representatives, dealers, and biomedical engineers. Job Type : Full-time, Permanent Salary Range : Php 30,000 - Php 35,000 Qualifications Graduate of Bachelor of Science in Pharmacy, Chemistry, or equivalent. Must have a valid PRC license. With at least 1 year of work experience in MEDICAL DEVICES. Knowledge and skills in Regulatory Documentation, Compliance, and understanding of Regulatory Requirements specific to medical devices. Responsibilities Ensures that the company complies with all applicable regulations regarding licenses, technical documents, and product registrations such as, but not limited to: Initial application and renewal of License to Operate (LTO), Registration and Renewal of Certificate of Medical Device Notification/Registration (CMDN/CMDR) to all products carried by the company, Amendments as required by the FDA or any agency involved in the regulation of Medical Devices. Represent the company and serve as a liaison with regulatory authorities, including, but not limited to, the Food and Drug Authority (FDA), ensuring compliance with inspection requirements and promptly providing accurate information to queries. Monitors and updates records of distribution for various products distributed and sold by the company. Assist the inventory associates in checking the deliveries from the principals to confirm that the quantities, product numbers, and descriptions match the purchase order and packing list. Monitor and assist the ISO certification process, ensures that the company meet all relevant international standards and regulatory requirements. Uphold and promote the company’s ethical standards; conducting seminars and training as needed to ensure compliance across all levels of the organization. Liaise with and report to foreign principals for regulatory requirements and the status of product registrations. Contributes to team efforts by achieving related results as needed. Seniority level Entry level Job function Legal Industries Medical Device We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

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