Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Timeline
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Robert Wayne Churinetz

Germantown

Summary

Results-driven President and CEO with expertise in strategic planning, operational excellence, and compliance. Proven track record in leading cross-functional teams to deliver innovative wound care solutions and enhance product offerings.

Overview

14
14
years of professional experience

Work History

President and COO

The Wound Care Company USA
07.2020 - Current
  • Led cross-functional teams to develop and implement innovative wound care solutions while driving COGS down by 46%
  • Analyzed market trends and customer feedback to drive product enhancements and strategic initiative for wound healing.
  • Collaborated with healthcare professionals to deliver training on medical device usage and best practices.
  • Developed comprehensive project plans to ensure timely execution of product launches and improvements.
  • Spearheaded process optimization initiatives, resulting in improved operational efficiency and reduced turnaround times by more than 40%
  • Streamlined medical device procurement processes for cost savings and improved efficiency
  • Developed strong partnerships with cross-functional teams for improved collaboration and efficiency.
  • Mentored leadership team on effective decision-making

President and Founder, Regulatory Affairs

Regulatory Affairs Associates, LLC
07.2012 - Current
  • Led regulatory compliance initiatives, ensuring adherence to industry standards and best practices.
  • Developed strategic partnerships with stakeholders to enhance product approval processes.
  • Oversaw cross-functional teams in executing regulatory submissions for new products.
  • Streamlined internal processes to improve efficiency in regulatory documentation and review cycles.

Education

Bachelor of Science - Biological And Physical Sciences

University of Bridgeport
Bridgeport, CT
06.1983

Skills

  • Leadership team building
  • Organizational leadership
  • Strategic planning
  • Operational excellence

Accomplishments

  • Documented and resolved novel Medical Device which led to Market Clearance
  • Supervised team of 50 staff members.
  • Achieved Lean Operations by introducing Just in Time for Operational, Quality Systems,and Manufacturing .tasks.

Affiliations

Health Industry Manufacturing Associates

American Society of Microbiology

American Society for Testing and Materials International

American National Standards Institute

Pharmaceutical Technology

FDA Medical Device Advisory Committee

Timeline

President and COO

The Wound Care Company USA
07.2020 - Current

President and Founder, Regulatory Affairs

Regulatory Affairs Associates, LLC
07.2012 - Current

Bachelor of Science - Biological And Physical Sciences

University of Bridgeport
Robert Wayne Churinetz