A highly motivated professional with 15+ years of experience in the medical device industry. In-depth knowledge of the Code of Federal Regulations (CFR), Title 21 Part 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies and International Organization and Standardization (ISO) 10993 standards. Extensive proficiency as a GLP study director managing in vitro and in vivo biocompatibility safety studies intended to support all phases of product development – from early feasibility studies to commercial launch. Possesses strong leadership qualities and excellent interpersonal skills with proven abilities in project and personnel management, continuous improvement initiatives, and implementation of company policies with focus on quality and regulatory compliance. Demonstrated a consistent track record for working independently and collaboratively to accomplish critical project goals within established timelines. Selected accomplishments include:
- Accomplished implementation of operational excellence in the Biocompatibility Study Management team with focus on meeting regulatory requirements for nonclinical safety studies.
- Developed and conducted training modules for scientists and engineers involved in initiating Edwards Quality Laboratories (EQL) submissions using the Laboratory Information Management System (LIMS).
- Experience as the biocompatibility expert participating in FDA, DEKRA, and TÜV inspections.
- Participated as a panelist representing the Edwards Quality organization in the Chinese FDA Panel Meeting for the approval of Edwards product in China.
- Played an integral role in a remediation project by collaborating with Parexel consultants in evaluating 300+ nonclinical studies.
- Elected as the Chairman of the 2016 Edwards Lifesciences Science and Technology Symposium – an annual forum which brings together researchers and engineers within Edwards Lifesciences to share and highlight current research activities.
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