Ofir Even Zohar
Quality Assurance And Regulatory Affairs Consultant
Rehovot
Summary
Experienced professional in quality assurance and regulatory affairs within the medical device industry. Demonstrated success in managing FDA and CE regulatory submissions, implementing ISO 13485 quality management systems, and leading cross-functional projects. Known for quick learning, meticulous attention to detail, and strong problem-solving abilities. Committed to ensuring product compliance and driving quality and operational efficiency enhancements.
Overview
7
7
years of professional experience
4
4
years of post-secondary education
Work History
Quality Assurance/Regulatory Affairs Consultant
Qsite
Rehovot, Central District
01.2021 - Current
- Lead the establishment and implementation of quality management systems according to ISO 13485 in diverse medical device classifications companies, including participating in internal and external audits by regulatory bodies.
- Managed regulatory submissions for FDA, European CE-MDR, Health Canada, AMAR, including the preparation and submission of technical documentation and on-going contact with Notified Bodies / competent authorities, with a focus on efficient and timely clearance.
- Participated Design control activities, Post-market surveillance, Risk management and Validation activities.
- Specialize in sterilization and cleaning, including Biocompatibility.
Research and Development Engineer
Strauss Group
02.2020 - 01.2021
- Directed pilot studies and established product specifications for global market, working in collaboration with cross-functional teams.
- Managed multiple concurrent projects effectively, ensuring all deadlines were met and resources utilized efficiently.
Quality Assurance Manager
Cofix factory
Yavne, Central District
04.2018 - 02.2020
- Established and maintain ISO 9001 and HACCP to ensure compliance with food safety regulations
- Performed root cause analysis to identify and resolve quality issues and defects.
- Led small team in managing quality operations, encompassing data collection and analysis, and implementation of corrective measures.
Education
Bachelor of Science - Biotechnology and Food Engineering
Technion
Israel 10.2015 - 08.2019
Skills
Management Skills
Fast learning
Creativity
Critical Thinking
Leadership
Product Lifecycle Management
Teamwork and Collaboration
Multitasking Abilities
Languages
Hebrew
Proficient
C2
English
Proficient
C2
References
References are available on request.
Projects
Final project: Operated by EIT Food in collaboration with students from Finland, Spain, and Germany., Development of a dairy product with citrus fibers using milk industry side stream.
Coursework
- Regulatory Affairs in Biotechnology
- Quality Management
- Bioprocess Engineering
Interests
Basketball player
Timeline
Quality Assurance/Regulatory Affairs Consultant
Qsite
01.2021 - Current
Research and Development Engineer
Strauss Group
02.2020 - 01.2021
Quality Assurance Manager
Cofix factory
04.2018 - 02.2020
Bachelor of Science - Biotechnology and Food Engineering
Technion
10.2015 - 08.2019
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