Insulet Corporation

  • Regulatory Affairs Associate

    Job Locations US-MA-Acton | US-MA-Billerica
    Posted Date 2 months ago(10/30/2018 11:09 AM)
    Category
    Regulatory Affairs / Clinical Affairs
  • Position Summary

    The position of Regulatory Affairs Associate will be responsible to provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in both the U.S. and global regions. Provide regulatory support to marketed products and ensure company’s regulatory compliance status.

    Responsibilities

    • Manage regulatory databases (e.g. regulatory files, technical files, standard documentation, labeling)
    • Assist in preparation of regulatory submissions and strategies for US and OUS (510(k)s, technical files, design dossiers)
    • Manage and review, from a regulatory perspective, advertising and promotional content
    • Work with Regulatory Management and Regulatory Specialists to support product development teams in providing direction on regulatory requirements and strategy
    • Research technical requirements for regulatory databases
    • Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
    • Support the development and implementation of regulatory processes, procedures, and standards as assigned.
    • Monitor and review technical standards for medical devices
    • Support audits from regulatory bodies (e.g. FDA, notified body)

    Education and Experience

    Minimum Requirements:

    • Bachelors Degree Required, with emphasis on life science or engineering preferred.
    • Minimum of 0-2 years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers).
    • Good oral and written communications skills and ability to work on cross-functional teams.
    • Working knowledge electronic documentation and information systems.

     

    Preferred Skills/Competencies:

    • Effective verbal and written communication skills
    • Ability to communicate at multiple levels of an organization
    • PC skill, word processing, spreadsheet, database
    • Ability to organize and manage multiple priorities
    • Ability to generate and maintain accurate records

     

    Physical Requirements:

    • None

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