Helit Dovrin

After 26 years at world leading medical device companies, where I held management & leadership roles in Quality Assurance and Regulatory Affairs, I have decided to take my own path in impacting lives and share my knowledge and experience with companies & organizations in the medical field (medical device, biotech, pharma, etc.) who want to grow, lead, and impact their employees, customers, and patients’ lives. 

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While working with companies like Philips Healthcare, GE Healthcare, Align Technology, and Biosense Webster (part of Johnson & Johnson) I have gained experience & expertise in all areas of the Quality Management System and Regulatory Affairs including FDA & Notified Body Inspection Management, ISO-13485, EUMDR & MDSAP Compliance Audits, and Quality & Safety escalations. 

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Managing & advancing in the corporate world has given me the opportunity to observe the challenges and to create solutions that impact women’s career progression as well as growth and leadership opportunities in many ways, including through direct management, 1-on-1 and group mentoring, coaching, as well as developing & executing women leadership programs.  

 

I am a certified Lead Auditor, Executive Coach, people leader, and mentor, who lives & breathes Quality and Compliance in all aspects - training, guiding, planning, and execution.  

 

My expertise include - FDA Inspection Management, ISO-13485, EU MDR and MDSAP Compliance Audits, ANVISA (Brazil) Inspection Management, Quality Planning, Production and Process Controls, Supplier Management, Risk Management, Formal Management Reviews, Post-Market Surveillance and Reporting, Internal Auditing, UDI Implementation, Product Development and Design Controls, Verification and Validation, CAPA Program Management, Regulatory strategy and planning for EU MDD/MDR (CE), FDA, China FDA, Health Canada, ANVISA, Japan and Australia.