Compliance Officer
Aljeron Medical Enterprises, Inc.
- Mandaluyong, PhilippinesMandaluyong, Metro Manila, PhilippinesMandaluyongMetro ManilaPhilippinesPhilippines
- Full timeFULL_TIME
Posted 12 days ago and deadline of application is on 10 Oct
Recruiter was hiring 6 days ago
2024-09-24T02:59:55.955918+00:002024-10-10T16:00:00+00:00Job Description
- 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.
Minimum Qualifications
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Graduate of Bachelor of Science in Pharmacy, Chemistry, or equivalent.
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Must have a valid PRC license.
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With at least 1 year of work experience in the regulatory industry, preferably in Medical Devices.
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Experience with ISO certification (i.e., ISO 13485) is an advantage
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Knowledge and skills in Regulatory Documentation, Compliance, and understanding of Regulatory Requirements specific to medical devices.
Jobs Summary
- Job Level
- Associate / Supervisor
- Job Category
- Health and Medical
- Educational Requirement
- Bachelor's degree graduate
- Office Address
- Mandaluyong, Metro Manila, Philippines
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About 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.