About
Accomplished multilingual engineer with 23+ years global medical device experience.
Knowledge in the areas of regulatory affairs, regulatory compliance, quality assurance and risk management from initial phases of product development to commercialization/post-market activities. Successful US – PMA, 510(k), European, Canadian and global device regulatory approvals.
Recognized leader with strong planning, strategic, negotiation and interpersonal skills.
Experience
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Head of Regulatory Affairs and Compliance at Bloomlife Inc
Nov 2020 - Present · 5 yrs 8 mos
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VP, Quality and Regulatory Affairs at Defibtech, LLC
Jul 2019 - Jun 2020 · 1 yr
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Director Regulatory Affairs and Quality Assurance at Neurologica
May 2018 - Jul 2019 · 1 yr 3 mos
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Director Regulatory Affairs at MOTUS GI Medical Technologies Ltd.
Mar 2017 - Apr 2018 · 1 yr 2 mos
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Nipro Diagnostics Inc. (5 yrs 7 mos)
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Senior Manager, Global Regulatory Affairs
Apr 2014 - Dec 2016 · 2 yrs 9 mos
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Manager, Global Regulatory Affairs
Jun 2011 - Apr 2014 · 2 yrs 11 mos