Insulet Corporation

Regulatory Affairs Manager

US-MA-Billerica | US-MA-Billerica
2 weeks ago
Category
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) medical device systems and digital health technologies. Attention to digital health technology, software, compliance, substantial equivalence, design control, change control, manufacturing, and post market activities are all essential to this role.

Responsibilities

  • Provide leadership and support to Research and Development, Quality Assurance, Commercial, Operations, and Insulet partners, for all devices (including software).
  • Lead regulatory efforts for development and maintenance of digital health technologies, including software as a medical device.
  • Lead regulatory efforts for new product development and supporting currently marketed devices.
  • 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 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.
  • Assist with 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 5 years of experience Regulatory Affairs in a medical device function
  • 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

 Skills/Competencies

  • Effective verbal and written communication skills
  • Able to work independently with teams in a fast-paced environment

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