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Alameda

    Regulatory Specialist - Alameda, United States - Planet Pharma

    Planet Pharma
    Planet Pharma Alameda, United States

    4 weeks ago

    Default job background
    Description

    Duties:

    • Responsible for implementing and maintaining the effectiveness of the quality system.
    • Supports manufacturing/operations day to day activities for change control.
    • Provides consultation/advice to regulatory specialist for change control and product development.
    • Provides regulatory direction/interpretation on team activities.
    • Interprets and applies regulatory understanding to support of products and teams.
    • Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
    • Handles regulatory activities involved in documentation, labeling, field support.
    • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
    • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
    • Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
    • Responsible for regulatory activities, including product registrations, impact assessment, etc.
    • Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
    • Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
    • Plan and execute the given tasks proactively in a timely manner.
    • Report the status to a manager weekly.
    • Keep the training records up to date to do the tasks.
    • Knowledge of International Standards, such as ISO13485, IEC60601.
    • Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
    • Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.
    • Ability to manage time and projects.

    Skills:

    • Knowledge of regulations and standards affecting IVDs and/or biologics
    • Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
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