Jobs

    RA Executive - Singapore - CLEARLAB SG PTE. LTD.

    CLEARLAB SG PTE. LTD.
    CLEARLAB SG PTE. LTD. Singapore

    1 week ago

    Default job background
    Description
    Roles & Responsibilities

    Responsibilities:

    • To prepare and compile all necessary and required application and technical documentation for all marketed countries, including EU CE, US FDA and Singapore HSA for Clearlab Group.
    • To conduct and compile Post-Market Surveillance activities, including Adverse Event Reporting, Product Recall, Periodic Safety Update Report (PSUR) for Clearlab Group.
    • To update, monitor and maintain marketed country Product Registration, Trademark License Listing and other related Licenses.
    • To update and maintain Technical Files, CSDT and any relevant Product Registration Technical Files.
    • To update and maintain Artworks and Packaging Labels, including Device Labels, IFU for all marketed markets.
    • To support QMS activities to ensure compliance with regulatory requirements.
    • Support in internal and external audits and other ad-hoc duties.
    • To support Document Control Centre as and when required.

    Requirements:

    • Minimum Diploma in any science field
    • ISO 13485 Lead Auditor
    • Minimum 1 year in regulatory related experience in a medical device or GMP related industry
    • Experienced in Optical devices / IVD media fill
    • Understanding of EU MDR 2017/245, ISO 13485 requirements
    • Understanding of related Regulations and GMP requirements
    • Able to use Microsoft Office i.e., MS Excel, MS Words
    • Must be able to read, write and communicate fluently in English.
    • Technical writing skills
    • Results-oriented, meticulous and an initiative-taking collaborator.
    • Effective decision-making capabilities
    • Able to converse in another language (Chinese, Malay, Indian)
    Tell employers what skills you have

    Technical Documentation
    Microsoft Office
    FDA
    Food Safety
    Labels
    Technical Writing
    ISO
    GMP
    Auditor
    Surveillance
    Packaging
    Audits
    Food Science
    Regulatory Requirements
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