Michael Schefke
Regulatory Affairs Specialist Iii at Hologic, Inc
Based in Orange County, United States
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Seniority
Staff
Department
Science
Location
Orange County
Industry
Medical Equipment Manufacturing
Company size
6.7K
Contact information
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m•••••••@hologic.com
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Background
About Michael Schefke
Collaborative, solution-oriented leader with 6 years of global RA/QA, project management, and sales and marketing experience in the medical device and diagnostic industries. Successful track record supporting pre-market 510k submissions, 5 Q-Submissions, 20+ post-market surveillance plans and reports, 1 EUA, 5 Technical Files, 2 CER’s, and international device registrations for 30+ countries. Responsible for development of company-wide MDR/IVDR post-market surveillance remediation program and C-level market access strategies. Experience working with the following product types: neurovascular stroke solutions, in-vitro diagnostic devices and assays, orthopedic, spine, and trauma.
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