Insulet Corporation

  • Regulatory Affairs Manager

    Job Locations US-MA-Acton | US-MA-Acton
    Posted Date 6 months ago(2/15/2019 8:40 AM)
    Regulatory Affairs / Clinical Affairs
  • Position Summary

    The Regulatory Affairs Manager will be responsible for supporting US and International product launches and maintenance. This includes Class II and Class III (US), Class IIb and Class III (EU), and Class II and Class III (Canada) device systems.  Attention to safety, efficacy, compliance, substantial equivalence, design control, change control, manufacturing, and post market activities are all essential to this role.



    • Provide regulatory leadership and support to Research and Development, Quality Assurance, Commercial, Operations, and Insulet partners, for all insulin devices.
    • Lead regulatory efforts for new product development and supporting currently marketed devices, including filing 510(k), PMA, PMA Supplements, CE Marking assessments, Health Canada License Submissions, and other international submissions.
    • Review, evaluate, compile files and reports and prepare document packages for regulatory submissions, including 510(k), Pre-submission documentation and Technical Files.
    • Represent Regulatory Affairs in core team meetings.
    • Provide regulatory impact assessments and risk/benefit analyses with respect to sustaining and continuous improvement endeavors.
    • Establish regulatory and quality strategies at earliest stages of design change or improvement.
    • Review all Engineering Change Orders for effect on the substantial equivalence or pre-market approval of Insulet products.
    • Assist Insulet partners with device related changes to their 510(k), PMA, NDA or BLA products.
    • Establish and maintain design control, risk management, clinical, and post market procedures.
    • Perform post-market clinical follow-up and state-of-the-art reviews.



    Education and Experience

    Minimum Requirements:

    • BS in a technical discipline, engineering preferred, MS ideal
    • Minimum of 7 years of experience Regulatory Affairs in a medical device company
    • Solid understanding of requirements for 510(k) submissions and technical file experience
    • Thorough understanding of ISO 13485, 21 CFR 820, ISO 14971, IEC 60601, IEC 62304
    • Experience with 510(k), IDE, PMA, CE Marking


    Preferred Skills/Competencies:

    • Effective verbal and written communication skills
    • Able to work independently with teams in a fast-paced environment
    • Ability to organize and manage multiple priorities
    • Manage staff as needed


    Physical Requirements:



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