Regulatory Compliance Officer

3 weeks ago

Mandaluyong City, National Capital Region, Philippines Aljeron Medical Full time
Regulatory Compliance Officer (Medical Device)

Overview

Regulatory Compliance Officer (Medical Device)

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.

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.
Job Details

Job Types: Full-time, On-site, Permanent

Salary Range: 30,000 - 35,000

Seniority level
  • Entry level
Employment type
  • Full-time
Job function
  • Legal
Industries
  • Medical Device

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