Avivit Spector

Responsible for reviewing and adequately assessing regulatory reportability for surgical devices class II and IV. understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820, 21CFR806, and 21CRF803. Ensure reportable events are communicated to the appropriate medical device authority (Europe, Japan, Israel, and Canada). Lead development and optimization of applicable policies and procedures. • File malfunction reports and serious injury MDRs. • Escalate adverse events and incident report analysis. • Approve final complaint file for closure after all applicable actions are completed. • Provide peer review and feedback on complaints and reports. • Manage and review 2300+ complaints for reportability to FDA through Medical Device Reports. • Contribute to creating new hire and regulatory-compliance training. • Leading development, optimization, and execution of various policies, protocols, and procedures (SOPs) in support of corporate, divisional, and regulatory needs. • Submit initial, and follow-up reports to device-related agencies as appropriate. • Review and analyze trending report data. • Recommending corrective and preventive actions to address non-conformities and deviations. • Maintain up-to-date records on CHS TrackWise and trained new hires. • Support multiple external audits.

Working directly with the CEO and lead project manager with regards to core company projects. • Maintained regulatory intelligence - analyzed and created executive summaries to keep up with new guidance and regulations • Performed MDD to EU MDR gap analysis and recommend changes to SOPs. • Reviewed and approves labelling and instruction for use to align with the changing requirements. • Compiled data relates to condition complaints and business issues. • Assists in the development, maintenance, and implementation of SOPs. • Helped to updates technical files/dossiers/registrations. • Reviewed technical literature related to product specifications consistent with domestic and international regulations.

I conducted my applied project on Pharmacogenetics mentored by Prof. Carl Yamashiro of ASU and Chris Yoo, the CEO of System Imagination INC.

Developed a holistic approach to treating children diagnosed with fatty liver disease under supervision from Dr. Tamir Miloh (Director of Pediatric Hepatology and Liver Transplant). • The program was recognized as a huge success by Dr. Miloh, leading to significant and sustained lifestyle changes in the lives of both patients and their families. • Provided ongoing direction and leadership for program operations. • Developed and recommended policies and procedures for evaluating programs. • Developed, coordinated, and administered the program. • Devised, implemented, and monitored program plans and schedules. • Met and collaborated with Dr. Tamir Miloh to uncover issues, identify applicable solutions, and offer guidance. • Developed first-rate training programs. • Worked alongside physicians, physiologists, child life personal, nutritionists, chefs, and personal trainers to outline and implement program plans and objectives. • Evaluated program operations, successes, and deficiencies to identify concerns and recommend strategies to enhance processes and elevate results. • Implemented strategies to increase program effectiveness.