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Denise Haley

Denise Haley

Medical Device Quality & Regulatory Affairs Consultant/Independent Contractor

Miami Beach, Florida

-ASQ Certified Biomedical Auditor
-RAC Certified, Medical Devices
 Over 20 years experience in the Medical Device Industry; experienced Quality Assurance/Quality Systems & Regulatory Affairs Manager
 Working knowledge of FDA QSRs, ISO 13485, EU MDD, EU MDR
 Responsible for over 20 successful FDA 510(k) submissions as well as Health Canada Licenses and worldwide radio licenses
 Working knowledge of wireless medical devices and radio/telecom regulations
 Experienced project manager and highly successful people manager; voted #2 in all of Philips Electronics for “delighting customers” (June 2009)
 Merger and acquisition due diligence and business integration leadership
 Highly organized and self-motivated to complete projects on time or earlier; leader for multiple quality improvement initiatives
 Work experience in many facets of industry: RA, QA, QC, Manufacturing, Service, Customer Support, Marketing, Training, and Project Management

Specialties:
-USA and International Regulatory Affairs for medical devices
-Quality Systems
-Quality Assurance/CAPA
-Auditing
-Q&R due diligence for mergers and acquisitions


Experience:

  • Instructor (Boston University Medical School)
  • Director of Quality Assurance and Regulatory Affairs (Harvard Apparatus, a Harvard Bioscience company)
  • Quality & Regulatory Consultant/Independent Contractor--Medical Devices (Independent Consultant)
  • Sr. Manager, Quality and Regulatory Affairs (Philips Healthcare)
  • East Coast Regulatory Manager; Quality Systems and Regulatory Affairs (Symmetry Medical Systems)

Skills:

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