Dawn Haake
Experience37+ Years
LevelCXO

Executive Overview

Patient focused Global Regulatory Compliance Professional with over 35 years in the Medical Technologies Industry. Primary responsibilities emphasize the implementation and assessment of business systems and the development of teams to manage and grow an efficient and compliant organization. From regulatory strategies to CAPA programs, training development and implementation, logistics, manufacturing control and monitoring, servicing, accounting and product development to developing innovative ways to adapt old paradigms to novel technologies (Human Tissue, Stem Cells, IoT, Cloud Based and Connected Care Solutions, SaaS and Mobile Medical Apps, LLM/AI), I’m always on the lookout for a good idea and a positive attitude. Team oriented with extensive experience working with executive management in the prevention and resolution of compliance issues.

Career Timeline

Professional employment history
  • ResmedCurrent
    Aug 2015–Present· 11 yrs 2 mos
    • Chief Quality OfficerCurrent
      May 2023–Present
    • VP Global Quality Assurance and Regulatory Affairs
      Sep 2018–May 2023
    • VP Global Regulatory Affairs
      Aug 2017–Sep 2018
    • VP Quality Assurance - Americas
      Aug 2015–Jun 2018
  • Jun 2006–Aug 2015· 9 yrs 2 mos
    • Sr. Director, Global Quality Assurance
      Jun 2006–Aug 2015
    • Sr. Quality Assurance/CAPA Specialist
      1997–Jun 2006
  • 1989–1997· 8 yrs
    • Technical Support Administrator
      1989–1997

Education

Bachelor’s Degree

Medical Quality Management Systems

University of Massachusetts Amherst

Human Biology

San Diego Mesa College

Associate of Science - AS

Science and Mathmatics

Palomar College

Humanities and Physical Sciences

University of California, Santa Cruz

Executive Relationship Map

Reports To
Dawn Haake
Vice Chair & President
Chief Financial Officer
Chief Technology Officer
Chief Operating Officer

Executive Network Preview

BizKonnect has mapped this leadership network including reporting hierarchies, peer connections, and cross-functional relationships.

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Skills & Expertise

20 of 20 skills
Product QualityISO 13485Global Regulatory ComplianceOrganizational LeadershipRegulatory SubmissionsQuality SystemCAPAProgram ManagementTraining & DevelopmentFDAAnalytical SkillsMedical DevicesQuality AssuranceClinical TrialsManufacturingAuditingExecutive ManagementDesign ControlRegulatory ComplianceInspection