RenalGuard® is the only clinically validated solution for preventing Acute Kidney Injury (AKI) in common hospital procedures, the 3rd leading cause of death and a $10B+ addressable market.

Synergy consulting provides regulatory and clinical affairs consulting to medical device and IVD start up companies across stages of product development.

Nucleix is a global IVD company focused on the development of multidisciplinary (reagents and software) cancer diagnostic tests based on DNA Methylation.> Grant the FDA Clearance for Bladder EpiCheck, Nucleix's first approved urine test for detection of recurrence of non-muscle invasive bladder cancer.> Establishing the company's Regulatory Affairs and Clinical departments including the development and execution of the company's US and EU regulatory and clinical strategy.> Responsible for all regulatory submissions and communications with the FDA and Notified Bodies including face-to-face meetings at the FDA.> Recruiting, managing and mentoring a Director of QA to allow the smooth transition to the new EU Regulations (IVDR) > Initiating and maintaining strong collaboration and partnership with internal cross-functional teams (R&D, Software, Commercial, Biostatistics, etc.) to power study designs/data analysis, evidence development and compliance with regulatory and quality requirements> Leading the clinical trials team which is responsible for the initiation and execution of global multicenter studies. > Ensuring that clinical trials are properly resourced, managed and executed within budget and in accordance with established timelines> Mentoring and developing the clinical team to maximize their capabilities and contributions to the organization. > Identifying, evaluating, and managing CRO activities, vendors, and other service providers including regulatory and quality consultants

Independen lecturer in GCP / CRA Course at Pharma-Job Biomedical College - Medical Device Regulations and Clinical Studies

Brainsway is a public company dedicated to providing treatment for a variety of psychiatry and neurology disorders. Brainsway's deep TMS is FDA cleared and approved by the Japanese PMDA and other regulatory authorities for treating major depression and other psychiatry disorders> Lead the global expansion of the Deep TMS technology to new territories > Managed regulatory submissions in Japan, Australia, Canada, Brazil, and other territories> Managing all aspects of post-marketing regulations > Establishing the business development and reimbursement department. Strategic management of all reimbursement activities in the US. > Leading a team of 4 US reimbursement professionals to support the company's clients for all reimbursement-related needs. > Initiating various clinical collaborations for post-marketing studies and new indications pipeline.> Create and maintain close and deep relationships with KOLs in the fields of neurology and psychiatry

Managing 22 sites multicenter study (US, Canada, Germany, France, Israel) to evaluate the safety and efficacy of the H-Coil for the treatment of Major Depression (MDD). The study was submitted to the FDA as part of the 510(k) submission which ends in the FDA clearance of the H-Coil for the treatment of MDD.Managing the company's regulatory interaction with different regulatory authorities.

- Senior consultant to various medical device companies developing regulatory strategy and clinical protocols to support regulatory submissions. - Managing the firm most strategic client, Brainsway Ltd. Serve as RA and clinical trials director at the client between the years 2010-2013.- Leading various FDA regulated multicenter studies from A to Z including clinical trials operations; budgeting and contracting, investigators meeting, site training and support, logistics, and monitoring.- Managing the firm clinical trials team working both in Israel and globally.- Senior team member for various FDA regulatory submissions; 510k, PMA, IDE, Pre-IDE etc including face-to-face FDA panel meeting, which lead to clinical studies and device approvals/clearance by the FDA. - Regulatory submissions to Health Canada, European Notified Bodies and AMAR.About A. Stein Regulatory Affairs Consulting:A. Stein Regulatory Affairs Consulting is one of the leading medical devices consultancy firms in Israel. The firm serves as one stop shop for all services related to medical devices regulations including regulatory affairs, clinical studies and QA.

- Turning the clinical trials department to an active department supporting both R&D and marketing activities to achieve company's goals.- Initiating and managing 6 single and multicenter clinical studies, in two years 3 times more compared to the same time period prior to joining the company.About Oridion Medical (Covidian):Oridion Medical (Covidian) is a global medical device company specializing in patient safety monitoring in clinical environments such as procedural sedation, operating rooms, critical care & post-anesthesia care units.

Managing a clinical study which aims to evaluate the efficacy of SAM-E (dietary supplement) on violence and aggressive behavior in schizophrenic patients

Managing all the Pharmacy activities including medical team education, logistics, budget and member of the institution Ethical Committee