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Director, Quality and Regulatory - Medical Device Capital Equipment

Needham, MA (On-site)

Agile Search is engaged with a commercial stage medical device innovation company building out capability to ensure successful, high quality product delivery to the customer.

You will directly advise the CEO on Quality and Regulatory policy and insight, as well as provide leadership to the organization's quality staff.


  • Set and achieve goals to launch and scale
  • Serve as the company's Management Representative
  • Oversee, improve and coordinate a highly functioning QMS
  • Responsible for overall product quality and tactics of ensuring on promises to our customer
  • Maintain inspection readiness and leading company compliance strategy
  • Hire and lead new employees
  • Plan for and evaluate daily quality operations
  • Present operational quality recommendations to the CEO for implementation


  • 10 - 15 years' experience with track record of quality leadership in an early stage medical technology company; including everything from improving quality policy and compliance to increasing inspection readiness and quality control of products.
  • 5+ years experience in an ISO 13485 environment with FDA inspection expertise
  • At least two years management experience in the regulatory affairs function
  • Strategic planning, business and technical experience driving execution in an early stage company
  • Executive communication skills


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