Insulet Corporation

  • Senior Regulatory Affairs Specialist

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 1 day ago(10/17/2018 10:45 AM)
    Regulatory Affairs / Clinical Affairs
  • Position Summary

    The Sr. Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including data and information analysis.  Additionally, the ideal candidate will provide regulatory support to marketed product and ensure regulatory compliance. 


    • Prepare and submit applications to the FDA and other regulatory bodies for new or modified software-based medical devices (e.g. 510(k)s, IDEs, PMAs, Qsubs, technical files)
    • Support in determination of regulatory requirements and strategies for new or modified software-based medical devices. Prepare required documentation as needed (e.g. Letter to file)
    • Represent Regulatory Affairs on project teams and provide direction regarding regulatory strategy.  Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc.
    • Establish internal systems to ensure regulatory approval and continued compliance of medical devices in both domestic and international markets
    • Assess organizational and product impact when regulations, directives, guidance, or standards change
    • Interact and negotiate with regulatory authorities in support of device clearance activities
    • Review, evaluate and approve Engineering Change Orders (ECO) for regulatory impact especially those concerning significant changes and revisions
    • Review and evaluation product and promotional labeling for compliance with applicable regulations
    • Maintain Regulatory records
    • Performs other duties as required

    Education and Experience

    Minimum Requirements:

    • B.S. / B.A.
    • Specialist level: 2+ years of regulatory medical device industry experience (510(k)s, Qsubs, CE mark, IDEs, PMAs) required. Sr. Specialist level: 4+ years of regulatory medical device industry experience (510(k)s, Qsubs, CE mark, IDEs, PMAs) required.


    Preferred Skills/Competencies:

    • Experience with software-based medical devices and cybersecurity is preferred
    • International regulatory experience (e.g. Health Canada, TGA) is a plus
    • RAPS (RAC) Certification is a plus
    • Must have analytical skills, be detailed oriented and have good interpersonal skills
    • Knowledge of global regulatory guidelines and requirements
    • 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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