Kris Kontis

Biotechnology Professional

Orange County, California Area

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Kris Kontis's Overview

  • Manager of Process Development at Hycor Biomedical Inc.

94 connections

Kris Kontis' Summary

Specialties: Molecular Biology & Genetics; Biochemistry; In Vitro Diagnostics (allergy, infectious disease); Medical Device Development

Kris Kontis' Experience

VP Regulatory Affairs

Medical Chemical Corporation

Privately Held; 11-50 employees; Biotechnology industry

March 2002Present (12 years 7 months)

March 2002 – Present (8 years 10 months)

Responsible for ISO and QSR compliance and CE marking; Serve as quality management representative during external audits of quality system; Oversee new product development and regulatory approval or clearance; Manage safety compliance and training; Administer continuation of permits, licenses and registrations with local, state, federal and international gencies; Write and/or approve quality system documentation; Interface with department managers in facilitating compliance; Provide management of laboratory testing of germicidal disinfectants and sterilants; Design and manage microbiology projects for validation of efficacy of disinfectants and sterilants; Coordinate and direct the submission of EPA and 510(k) registrations

Manager of Process Development

Hycor Biomedical Inc.

Privately Held; 51-200 employees; Medical Devices industry

19962001 (5 years)

Managed process transfer and optimization to facilitate product improvement and/or launch. Authored peer-reviewed papers on allergy and autoimmune diagnostics and presented findings at international scientific meetings.

Kris Kontis' Skills & Expertise

  1. Medical Devices
  2. Validation
  3. Technology Transfer
  4. Biochemistry
  5. Molecular Biology
  6. Regulatory Affairs
  7. Quality System
  8. Laboratory
  9. Infectious Diseases
  10. Cell Biology
  11. FDA
  12. Biopharmaceuticals
  13. Microbiology
  14. Lifesciences
  15. Biotechnology

Kris Kontis' Education

University of California, Irvine

Doctor of Philosophy (Ph.D.), Molecular Biology and Biochemistry


University of California, Irvine - College of Medicine

Ph.D., Molecular Biology & Biological Chemistry


Kris Kontis' Additional Information

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