Seeking a position which will allow me to execute as well as challenge my current skill set resulting in performance growth and advancement. Exceptional verbal/written communication, organizational, leadership, analytical, and interpersonal skills

Highlights:

Surpassed company goal of closing over 95% of customer complaints within the established internal target timelines

Companies I like:

Biomedical, Biotechnology, Healthcare compliance

• compliance
• Regulatory

• Received, investigated and closed complaints for Class III devices in a manner compliant with patient confidentiality, FDA regulations, ISO 13485, and ISO14971 standards and 21 CFR-820/803 guidelines • Monitored complaint activity for potential triggers or emerging trends; escalating issues to CAPAs as necessary. • Modified departmental procedures, researched and analyze complaints data for special projects, as well as assisting with implementing productivity improvements • Participated and provided support for external and internal audits, including FDA and Notified Body inspections • Participation in review of clinical trial complaints. • Responsible for MDR decisions for product complaints; submission of ASR/MDR reports