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Senior Quality and Regulatory Manager

Company: Canary Speech
Location: Provo
Posted on: August 2, 2022

Job Description:

Canary Speech is seeking an experienced Quality & Regulatory Manager to provide quality management and regulatory affairs leadership across the business within a highly regulated medical devices environment. The successful candidate will be responsible for management of the Quality Management System to the FDA CFR 21 part 820 and ISO 13485 standards and all regulatory submissions to the relevant authoritiesObjectives of this Role

  • Provide Quality & Regulatory direction, training and support to the Canary organization
  • Responsible for ensuring Canary business activities are conducted in compliance with the regulations and standards applicable to our business and product range
  • Plan and deliver the Regulatory registration / submission documentation required to achieve global market access
  • Ensure Canary product lifecycle activities meet the Quality & Regulatory requirements of applicable markets
  • Develop and maintain a Quality Management System in support of regulatory filings
  • Ensure Regulatory submissions and claims are fully supported by product documentation at all stages of the product lifecycle.
  • Responsible for planning and hosting external Quality audits / inspections of the Canary facilityRequired Skills and Qualifications
    • A Bachelor's degree in a relevant subject or suitable experience in a Regulatory/Quality role
    • Excellent knowledge of FDA CFR 21 Part 820 and ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions
    • Proven track record of regulatory submissions of technical files
    • Proven track record of preparing for and managing successful Quality audits / inspections
    • A QMS orientation, but pragmatic when working across functions
    • Self-motivated and "can do" attitude, a willing to be flexible, with an ability to adapt to change
    • An effective communicator

Keywords: Canary Speech, Provo , Senior Quality and Regulatory Manager, Executive , Provo, Utah

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