Insulet Corporation

  • Regulatory Affairs Associate

    Job Locations US-MA-Acton | US-MA-Acton
    Posted Date 1 month ago(1/15/2019 10:09 AM)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    The position of Regulatory Affairs Associate will be responsible to provide immediate administrative regulatory support to ensure timely introduction of advertising and promotion content in the U.S, as well as opportunity in the future to support 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 and administer regulatory processes, primarily advertising and promotional content, which includes activities such as data management and verification
    • Manage and review, from a regulatory perspective, advertising and promotional content
    • Support audits from regulatory bodies (e.g. FDA, notified body)
    • Support the development and implementation of regulatory processes, procedures, and standards as assigned.
    • Assist in preparation of regulatory submissions and strategies for US and OUS (510(k)s, technical files, design dossiers)
    • 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

    Education and Experience

    Minimum Requirements:

    • Bachelors of Science preferred
    • Minimum of 0-2 years knowledge and experience with regulatory or documentation control requirements for medical devices (e.g. documentation control, regulatory submissions).
    • Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards
    • Good oral and written communications skills and ability to work on cross-functional teams.
    • Working knowledge of electronic documentation and information systems.

     

    Preferred Skills and Competencies:       

    • Excellent organizational skills.
    • Excellent writing, proofreading, and verbal communication skills.
    • Experience collaborating and communicating with individuals at multiple levels in an
    • Ability to prioritize and meet deadlines.
    • Ability to manage multiple projects simultaneously.
    • Ability to generate and maintain accurate records.
    • High level of proficiency with MS Office programs; specifically Word, Excel, and PowerPoint applications.
    • Able to work effectively in a fast paced environment, while maintaining strong attention to detail.

    Physical Requirements:

    None

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