Global Regulatory and Product Registration Consultant
Zamir Bar-David is a seasoned regulatory and quality consultant with 35 years of experience in the medical device and pharmaceutical industries. Holding a Master's in Business Operations and a B.S. in Engineering, he leverages his background as a former Lead Auditor for Notified Bodies (Intertek, TUV Rhineland) to provide expert guidance. Zamir specializes in global product registrations across 60...
Experience: 35+ years
Zamir Bar-David provides regulatory consulting services to clients in:
This consultant's educational background provides a powerful combination of technical and business acumen, featuring a B.S. in Industrial Engineering and an M.A. in Business. The engineering degree establishes a strong foundation for understanding complex medical device design, manufacturing, and validation processes. This is complemented by a master's in business, equipping them with a strategic perspective on operations and quality management, making them uniquely capable of aligning regulatory strategy with commercial objectives for medtech companies.
As a member of the Regulatory Affairs Professional Society (RAPS), this consultant demonstrates a strong commitment to professional development and staying at the forefront of the evolving regulatory field. This affiliation ensures they are continuously updated on the latest industry trends, guidance, and best practices, providing clients with current and well-informed strategic advice.
With an impressive 35-year career in the medical device and pharmaceutical industries, this professional has a proven track record of leadership and regulatory excellence. Their experience includes pivotal roles such as Sr. Director of Global Regulatory Affairs and QA/RA Manager at prominent companies, including a consultant role at Stryker Orthopedics. A key differentiator is their direct experience as a Lead Auditor for Notified Bodies like Intertek and TUV Rhineland, which provides clients with an invaluable insider's perspective on audit readiness and compliance. Now operating as a global consultant, they leverage this extensive background to guide companies of all sizes through complex regulatory landscapes.
Zamir Bar-David is a seasoned regulatory and quality consultant with 35 years of experience in the medical device and pharmaceutical industries. Holding a Master's in Business Operations and a B.S. in Engineering, he leverages his background as a former Lead Auditor for Notified Bodies (Intertek, TU...
Zamir Bar-David offers medtech companies an exceptional strategic advantage, built upon 35 years of experience and a rare dual perspective as both a global consultant and a former Lead Auditor for top Notified Bodies (Intertek, TUV Rhineland). This 'insider's view' is invaluable for building robust, audit-proof Quality Management Systems (ISO 13485, MDSAP) and de-risking regulatory submissions. His proven track record of securing product registrations in over 60 countries, combined with deep expertise in US FDA 510(k) submissions and EU MDR technical documentation, demonstrates a mastery of the most critical global markets. Zamir's engineering and business background further empowers him to translate complex regulatory requirements into actionable commercial strategies, making him a comprehensive partner for market success.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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