Relu Segal
About Relu Segal
Relu Segal is a Regulatory Affairs Specialist at Novocure Inc. in Haifa, MATAM, with extensive experience in regulatory submissions and compliance for high-risk medical devices.
Title and Current Position
Relu Segal holds the title of Regulatory Affairs Specialist and is currently working at Novocure Inc. in Haifa - MATAM. In this role, Segal is responsible for managing regulatory submissions, ensuring compliance with various international standards, and supporting quality assurance activities.
Educational Background
Relu Segal graduated from the Technion - Israel Institute of Technology with a B.Sc. in Electrical Engineering. The program, which spanned from 2001 to 2005, equipped Segal with a solid foundation in engineering principles and practices, which have been applied throughout a career in regulatory affairs and compliance for medical devices.
Previous Work Experience
Before joining Novocure Inc., Relu Segal served in several roles with a focus on regulatory affairs and compliance. From 2012 to 2013, Segal was a Regulatory Engineer at Venus Concept in Yokneam, R&D. Prior to that, Segal worked as a Regulatory Affairs Specialist at Lumenis from 2008 to 2012, in the same role at MIS dental implants from 2007 to 2008, and as a Medical Devices Compliance Engineer at The Standards Institute of Israel from 2006 to 2007.
Regulatory Affairs Expertise
Relu Segal has extensive experience in preparing regulatory submissions for high-risk medical devices across multiple international markets including the FDA, EU, and Japanese PMDA. Segal handles submissions for changes in design or manufacturing of Class III medical devices and supports medical device companies during international registrations and CE audits.
Compliance and Quality Assurance
As a Regulatory Affairs Specialist, Relu Segal leads quality assurance activities to ensure compliance with design control requirements. Segal is knowledgeable in designing sterilization, biocompatibility, and risk management processes according to ISO 14971 standards. Additionally, Segal ensures compliance with IEC 60601-1 third edition for medical devices.
Novel Cancer Treatment Device
Relu Segal has been involved in the regulatory affairs for a novel cancer treatment device that uses Tumor Treating Fields (TTF) technology. The device, which has received approvals from both the FDA and Japanese PMDA, is known for being as effective as dedicated chemotherapy but without the serious side effects typically associated with chemotherapy.