Regulatory Affairs and Quality Assurance Officer - Quezon City - Plastilens International Inc.

    Plastilens International Inc.
    Plastilens International Inc. Quezon City

    1 araw ang nakalipas

    Paggawa / Mekanikal
    Paglalarawan

    Company Description

    Plastilens International Inc. is a longstanding and esteemed ophthalmic lens laboratory in the Philippines, established in 1976. As a pioneer in the optical lens industry, Plastilens partners with leading optical clinics and eye centers to deliver products adhering to international quality standards, utilizing advanced European equipment. The company values its employees as integral to its growth and fosters a collaborative and supportive environment where everyone is treated as family. With a commitment to quality and a positive workplace, Plastilens invites committed professionals to join its team in achieving shared success.

    Job Summary

    The Regulatory Affairs and Quality Assurance Officer will support the company in ensuring that all ophthalmic lenses and related products comply with FDA and other applicable regulatory requirements. This role involves preparing and submitting documents for FDA registration, maintaining regulatory records, and assisting in the implementation and monitoring of quality assurance systems within the company.

    Key ResponsibilitiesRegulatory Affairs (FDA Focus)
    • Prepare and submit documents for FDA registration, renewal, and amendments.
    • Coordinate with internal teams to complete regulatory requirements.
    • Track and monitor the progress of product applications.
    • Stay updated on FDA rules affecting ophthalmic lenses.
    • Maintain organized regulatory files, licenses, and certificates.
    Quality Assurance
    • Assist in developing and implementing quality procedures.
    • Coordinate with all departments to maintain and update Standard Operating Procedures (SOPs), forms, and reports.
    • Support production and inspection activities for compliance.
    • Participate in internal audits and prepare related reports.
    • Maintain quality records and documentation logs.
    • Help prepare for external audits and inspections.
    Cross-Functional Coordination
    • Coordinate with Engineering, Production, and Sales to ensure product compliance.
    • Review product labels and materials for FDA compliance.
    • Work with all departments to maintain and update Standard Operating Procedures (SOPs), forms, and reports.
    Documentation and Reporting
    • Keep databases and files of registrations, certificates, and reports.
    • Prepare summaries and status updates for management.
    Qualifications

    Education: Bachelor's degree in Pharmacy, Biology, Chemistry, Chemical Engineering, or a related science or business management course.

    Experience:

    At least 1–2 years of experience in regulatory affairs or quality assurance (experience with FDA applications for medical devices or pharmaceuticals is an advantage).

    Fresh graduates with strong attention to detail and willingness to learn are encouraged to apply.

    Knowledge/Skills:

    • Basic understanding of FDA processes and quality systems.
    • Strong organizational and documentation skills.
    • Good communication and coordination skills.
    • Proficient in MS Office (Word, Excel, PowerPoint).
    • Ability to work independently and manage multiple tasks.
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