Compliance Officer
Aljeron Medical Enterprises, Inc.
- Mandaluyong, PhilippinesMandaluyong, Metro Manila, PhilippinesMandaluyongMetro ManilaPhilippinesPhilippines
- Toàn thời gianFULL_TIME
Đăng ngày 12 days ago và hạn chót nộp hồ sơ vào ngày 10 Oct
Nhà tuyển dụng đăng tin 6 days ago trước
2024-09-24T02:59:55.955918+00:002024-10-10T16:00:00+00:00Miêu Tả Về Công Việc
- Ensures that the company complies to 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.
Trình độ tối thiểu
-
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 the regulatory industry, preferably in Medical Devices.
-
Experience with ISO certification (i.e., ISO 13485) is an advantage
-
Knowledge and skills in Regulatory Documentation, Compliance, and understanding of Regulatory Requirements specific to medical devices.
Tóm tắt công việc
- Trình Độ Công Việc
- Phó Giám Sát/Giám Sát
- Ngành Nghề
- Health and Medical
- Yêu cầu học vấn
- Tốt nghiệp Cử nhân
- Địa chỉ văn phòng
- Mandaluyong, Metro Manila, Philippines
- Ngành nghề
- Medical Equipment
- Vị trí đang tuyển
- 1 vị trí tuyển dụng mới
- Trang web
- https://aljeronmedical.com/
Feel secure when applying: look for the verified icon and always do your research on a company. Avoid and report situations when employers require payment or work without compensation as part of their application process.
Về Aljeron Medical Enterprises, Inc.
Aljeron Medical Enterprises (AMEI) is a licensed servicer, importer, and distributor of various surgical, diagnostic, laboratory, and radiological equipment and devices. With a strong network and dedicated team, AMEI has grown to become a reputable company in the industry. Headquartered in Metro Manila, AMEI operates nationwide through its sales representatives, and biomedical engineers.