Experience

X-trodes
• Israel
• Hospitals and Health Care
• 1 - 100 Employee
• VP Clinical Affairs and Regulation

  • Aug 2022 - Present


NAAMA Studios

• United Kingdom
• Wellness and Fitness Services
• 1 - 100 Employee

• VP Clinical and Regulatory Affairs

  • Jul 2019 - Aug 2022

  Dermatology medical device based laser system for pigment/tattoo removal • Built and implemented clinical and regulatory strategy for the company • Created and managed clinical professional network in US and Europe • Led FDA pre-submission and submission process, and achieved 510K FDA approval • Managed strategic clinical study in Lithuania following the FDA guidelines • Led submission process and achieved CE and ISO13485 approval • Achieved Australia TGA and Israeli AMAR certificates • Managed medical and clinical aspects of the London studio for tattoo removal Show less



Kamedis Ltd.

• Israel
• Personal Care Product Manufacturing
• 1 - 100 Employee

• VP Clinical, Regulation and QA

  • Sep 2015 - Jun 2019

  Dermatology medical solutions; developing and marketing treatments for skin conditions • Initiated and managed multi center clinical trials in US, EU, Philippines and Israel • Managed FDA, CE, CFDA, Taiwan, Philippines, submissions through approval • Established network of key opinion leaders physicians, academic researchers to engage in supporting company marketing and clinical activities • Lectured and presented the company's clinical activities in leading dermatology conferences in the US, China and the Philippines. Published numerous peer reviewed research papers • Developed, planned and implemented company process for new products targeting the US Show less



WideMed Ltd.

• VP Clinical Affairs

  • 2005 - 2014

  Signal Processing based medical company; developing and marketing analysis and information systems for sleep laboratories, cardiovascular in-patient departments and home applications VP Clinical Affairs (2008-2014) • Primary company interface with physicians, clinicians and academic researchers • Managed clinical research in several locations in US, Europe and Israel • Managed FDA, CE and CFDA submissions, and all company IP aspects • In charge of developing and publishing Widemed's papers in academic journals, trade journals and leading international conferences • Actively involved in company business development initiatives Director of Strategic Accounts (2005-2008) • Managed relationships with Widemed’s strategic clients • Headed company’s feasibility and implementation processes for top clients • Key role in Widemed’s business strategy and marketing strategy decisions • Formulated detailed competitive product strategy based on market opportunities, customer needs and competition Show less



RAMOT LTD., CARDIO-INSPECT PROJECT

• Business Development & Clinical Trials Manager

  • 2003 - 2005

  Medical device project in Tel-Aviv University; developing a diagnostic device for CHF patients • Part of the initiating and the fund raising team of the project • Created the business plan and market evaluation of the project Medical device project in Tel-Aviv University; developing a diagnostic device for CHF patients • Part of the initiating and the fund raising team of the project • Created the business plan and market evaluation of the project



SLO FLO Ltd.

• Business Development & Product Manager

  • 1999 - 2005

  Medical device startup; developing intrauterine insemination device Business Development & Product Manager • Formulated company’s business strategy, created business plan, performed market survey • Lead R&D efforts – managed outsourcing to 3rd parties as well as the engineering team Medical device startup; developing intrauterine insemination device Business Development & Product Manager • Formulated company’s business strategy, created business plan, performed market survey • Lead R&D efforts – managed outsourcing to 3rd parties as well as the engineering team



BARNEV LTD., MEDUCK TECHNOLOGIES LTD

• Business Development

  • 1999 - 2000

  Barnev develops a system for continuous monitoring of delivery process Meduck focused on PDA and disposable sensors for various medical applications • Business development and patent responsibility for both companies Barnev develops a system for continuous monitoring of delivery process Meduck focused on PDA and disposable sensors for various medical applications • Business development and patent responsibility for both companies