Insulet Corporation

Sr. Manager, Regulatory Affairs

US-MA-Billerica | US-MA-Billerica
1 month ago
Category
Regulatory Affairs / Clinical Affairs

Position Summary

In this highly visible role, the Senior Manager of Regulatory Affairs will be responsible for leading regulatory decision making for domestic and international product launches.  The incumbant will lead a team of highly engaged regulatory professionals in developing strategies and plans that will be critical to Insulet's success in the future.

 

 

Responsibilities

  • Provide leadership and support to Research and Development, Quality Assurance, Commercial, Operations, and Insulet partners, for all insulin devices.
  • Class II and Class III (US), Class IIb and Class III (EU), and Class II and Class III (Canada) device systems.

  • 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

  • BS in a technical discipline, engineering preferred, MS ideal
  • Minimum of 7 years of experience Regulatory Affairs in a medical device function
  • Solid understanding of requirements for 510(k) submissions and technical file experience
  • Attention to safety, efficacy, compliance, substantial equivalence, design control, change control, manufacturing, and post market activities are all essential to this role.
  • Thorough understanding of ISO 13485, 21 CFR 820, ISO 14971, IEC 60601, IEC 62304
  • Experience with 510(k), IDE, PMA, CE Marking is required

 

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

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