Regulatory Affairs Assistant – Indonesia

    Ditayangkan 16/September/2016

    • • Join Medtronic, the world's largest healthcare organisation
    • • Great Career Development Opportunity
    • • This role is a 6 months contract- maternity cover in Indonesia


    Main Purpose:
    • Managing compliance with regulatory MoH (Ministry of Health) controls by completing timely submissions and government filings for Legacy Covidien Product under PT Medtronic Indonesia
    • Leading and maintaining regulatory clearances, documentation and approvals with necessary filings and communications to appropriate parties
    • Managing communications with government and regulatory agencies
    • Working closely with the ARO and GBU RA to manage and implement regulatory strategy to submit a legacy Covidien Product to PT Medtronic Indonesia
    Key Accountabilities:
    • Reviews, analyzes and consolidates all relevant and related technical information from other stakeholders (e.g. GBU RA, marketing) to meet with the local regulatory agencies expectations for the approval of  Transfer License Project
    • Maintains post approval regulatory files and database appropriately to assure ability to track and use by other stakeholders
    • Collaborates and contributes regulatory expertise with local cross functions and Global RA Business Unit
    • Skill, Experience and Knowledge:
      • Minimum 1-2 year-experience in regulatory affairs of healthcare products, prefer in MNC medical device business, Fresh Graduate are welcome
      • Knowledge of Indonesia regulations for medical devices
      • Proven evidence of Medtronic Leadership Traits:
      • Shape- Demonstrates global business acumen, thinks critically and makes sound decisions, sets strategic direction
      • Engage- Collaborates and creates alignment; attracts, deploys, and develops talent; fosters diversity and inclusion
      • Innovate- Focuses on patient and customer, generates breakthrough ideas, initiates and leads change
      • Achieve- Sets high standards, instills operational excellence, drives accountability, models ethical behavior
    • Qualifications:
      • Computer literate prefer Microsoft software (i.e. Word, Excel, Outlook, etc.)
      • Verbal and written communication skill
      • Bachelor’s degree in health sciences e.g. Pharmacy or Medical Technology

    Tutup pada 16/October/2016

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