Regulatory / Quality Assurance Analyst

Regulatory Quality Assurance Analyst

Posted 1 day ago

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 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

• Additional leave
• Company events
• Health insurance

Application Question(s):

• What's your expected basic salary?
• Where are you currently residing?
• Are you willing to work on-site?

Education:

• Bachelor's (Required)

Experience:

• Regulatory Compliance: 1 year (Required)

License/Certification:

• PRC License (Required)

Posted 1 day ago

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 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.

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, On-site, Permanent

Salary Range: 30, ,000

Posted 1 day ago

The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA) Philippines, and ensuring that all products meet the necessary approval processes for marketing in the country.

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