Dana Leitman (Feingold) Email & Phone Number

Israel

• Strategic leadership overview and implementation of entire European regulatory strategy and requirements from a QA/RA perspective for to our current and future products• Competitive analysis from business perspective • Over-site of our scientific publication strategy • Business strategy for new products• Budgeting, partnerships and collaboration • Overall of project management at Moebius

End-to-end solution for MedTech innovation companies in Southeast Asia markets – Quality Assurance & Regulatory Affairs• Established boutique consultancy firm to support innovative and fast-growing MedTech start-ups in easing international development in Southeast Asia offering end-to-end solutions (including market research, fundraising, roadshows, and distribution)• Provide comprehensive go-to-market strategies (including product registration and regulatory strategy) helping companies to be active in Singapore and other Southeast Asia countries• Collaborate with leading VC firms in both Southeast Asia and Israel to build MedTech region capabilities • Digital Health regulation • Product registration in Asia (Singapore, Vietnam, Thailand, Korea, Japan and Australia)• Implement and consult Quality Management System (QMS) according to ISO13485:2016

Allschwil, Basel, Ch

Development and generation of our business in the Life Science/Healthcare industry in APACBuild life science/Healthcare market oversight for the APAC regionGo-to-Market strategy planning and execution of Arcondis healthcare professional services in APACManage Arcondis APAC P&LManagement consultant: Strategy, go-to-market, change management and digital transformation for our Pharma/MedTech clients

Singapore, Singapore, Sg

Singapore, Sg

• Completed external audits from the EU regulatory body resulting renewal of ISO 13485 aligned with FDA and other and other international standards; ensured all company’s devices including software & labelling meet all regulatory requirements• Led risk management and clinical evaluation projects to support on-going development of products• Managed product registration in South East Asia

Netanya, Israel, Il

• Joined as employee #2 – created and executed business development strategy, collaborating closely with technology scientists/engineers and all other departments, to identify constraints and resolutions• Presented technology and business value to international investors• Developed and conducted Risk Management, Clinical Evaluation, Post Marketing Surveillance and Pre-clinical Trails activities• Obtained ISO 13485 certificate win less than a year

• Combined a team of 3 at EON-Surgical, a small start-up, exit within a year when acquired by TELEFLEX (US$12B company)– responsible for handoff & knowledge transfer for minimally invasive micro laparoscopy surgical platform technology• Led Pop Medical (minimally invasive solution for uterine prolapse repair) regulatory strategy; worked on FDA approval – monitored clinical trials as Clinical Research Associate for various projects • Engage 2-years with Maxillent (Israeli start-up providing dental implants innovative solutions) worked closely with leadership team to define product development & international business development strategies

Ness Ziona, Il

• Successfully developed & patented Method and device for fast dissolution of solid protein composition (WO2013098805A1 WIPO)• Planned and execute pre-clinical trials using unique bio-surgery techniques resulted launching a new product line

Chesterfield, Mo, Us

• Collected and analysed data – secured health, safety and environment standard certificates (ISO 14001, ISO 18001)

Haifa, Il

• Conducted and published 3+ years of tissue engineering and nano-technology research an influential scientific journal:o Feingold-Leitman D., Zussman E., Seliktar D., In Vitro Evaluation of a Composite Scaffold Made from Electrospun Nanofibers and a Hydrogel for Tissue Engineering. Journal of Bionanoscience, Vol. 3, 1-13, 2009.

Haifa, Il

Teaching Assistant for undergraduate Bio-Medical Engineering students

Haifa, Il

Research in the field of organic chemistry

• Accomplished Medic course (volunteer basis) and served as an active Medic for 2 years (treating wounded soldiers during training and combat)

Executive Mba

M.Sc., Biotechnology

B.Sc., Chemistry