Insulet Corporation

  • Regulatory Affairs Specialist / Sr. Regulatory Affairs Specialist

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 2 weeks ago(3/13/2018 4:09 PM)
    Regulatory Affairs / Clinical Affairs
  • Position Summary

    The Regulatory Affairs Specialist/Sr. Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including data and information analysis.  Additionally, the Regulatory Affairs Specialist/Sr. Specialist 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 record
    • Performs other duties as required

    Education and Experience

    • B.S. / B.A. and/or an equivalent combination of education and experience
    • Specialist: 2+ years of regulatory medical device industry experience (510(k)s, Qsubs, CE mark, IDEs, PMAs). Sr. Specialist: 4+ years of regulatory medical device industry experience (510(k)s, Qsubs, CE mark, IDEs, PMAs)
    • 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


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