Moshe Cohen
@moshecohen
Experienced Regulatory Affairs Specialist in the medical device industry.
What I'm looking for
With a decade of experience as a Regulatory Affairs Specialist in the medical device industry, I have successfully provided expert services to numerous med-tech companies. My expertise encompasses preparing detailed regulatory documentation and submissions, as well as managing interactions with global authorities such as the FDA. I excel in navigating both U.S. and international regulatory frameworks, offering strategic and operational guidance to resolve complex regulatory challenges.
Throughout my career, I have demonstrated strong communication skills, effectively representing companies in discussions with regulatory bodies. My hands-on experience spans both large corporations and startup environments, allowing me to balance varying degrees of resources and constraints. My educational background in electrical engineering enhances my understanding of technical safety and performance standards within the industry, further solidifying my capability to lead regulatory efforts towards global approval.
Experience
Work history, roles, and key accomplishments
Senior RA Specialist
Medtronic
Oct 2021 - Jan 2025 (3 years 3 months)
Focused on regulatory affairs for patient monitoring technology, ensuring compliance with global regulatory standards and managing submissions to authorities like the FDA.
QA/RA Manager
Sonovia
Jun 2019 - Jun 2021 (2 years)
Responsible for overseeing all quality assurance and regulatory affairs activities, ensuring compliance with medical device regulations and standards.
QA/RA Specialist
Yakar Engineering
Sep 2014 - Jan 2019 (4 years 4 months)
Provided consulting services in quality assurance and regulatory affairs for various medical device companies, focusing on compliance and certification processes.
Education
Degrees, certifications, and relevant coursework
Technion Institute of Technology
Master of Business Administration, Business Administration
2012 - 2014
Earned a Master of Business Administration degree, focusing on business management and regulatory affairs.
Polytechnic Institute of NYU
Master of Science, Electrical Engineering
2010 - 2012
Grade: Summa Cum Laude
Completed a Master of Science in Electrical Engineering, graduating with Summa Cum Laude honors.
Polytechnic Institute of NYU
Bachelor of Science, Electrical Engineering
2006 - 2010
Grade: Summa Cum Laude
Graduated with a Bachelor of Science in Electrical Engineering, achieving Summa Cum Laude honors.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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