Contracts And Compliance Supervisor
3 weeks ago
Regulatory Compliance Officer
Posted 1 day ago
Job DescriptionQualifications:
- 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 9001:2015) is an advantage
- Knowledge and skills in Regulatory Documentation, Compliance, and understanding of Regulatory Requirements specific to medical devices.
Responsibilities:
- 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.
Company Description
Aljeron Medical Enterprises, Inc. (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, dealers, and biomedical engineers.
Job Types: Full-time, Permanent
Salary Considerations
Salary information listed as of posting: Local currency. (Note: Salary range shown in the original posting may be inconsistent; verify during interview.)
Education:
- Bachelor's (Required)
Experience:
- Regulatory Compliance: 1 year (Required)
License/Certification:
- PRC License (Required)
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