Emad Ramzi
Senior Regulatory Affairs Manager at Wellspect Healthcare
Based in Sweden
7-day free trial · no credit card
Seniority
Manager
Department
Legal
Location
Sweden
Industry
Medical Equipment Manufacturing
Company size
717
Contact information
Reveal Emad's email and phone
Direct contact data is gated. Sign up and reveal. You only pay for verified records.
e•••••••@wellspect.com
Phone
5 credits+46 ••• •••• ••••
You only pay for valid records. Bounced emails and disconnected numbers cost nothing.
Background
About Emad Ramzi
Senior Regulatory Affairs Manager with over 20 years of experience in the medical device industry. Specialized in premarket submissions for the U.S. market, with additional expertise in the conformity assessment of products for CE-mark application in the EU single market, as well as global registrations including Canada, Brazil, Russia, and Middle Eastern countries. Authored several U.S. FDA 510(k) submissions for a diverse range of medical devices, including urology devices and electronic, software-controlled bowel management systems. Extensive experience with the European Vigilance process, including incident reporting, FSCA, FDA medical device problem reporting, and voluntary recall processes. Proficient in EU Medical Device Regulation 2017/745, CFR Title 21, IEC 60601 series of technical standards for the safety and essential performance of medical electrical equipment, and internal audits according to ISO 13485.
Decision-makers
Other people at Wellspect Healthcare
Build a list of verified contacts at Wellspect Healthcare
Free for 7 days · 50 credits · no card · only pay for verified records.
Reach more buyers like Emad
250M+ professionals with verified email and phone. You only pay for records that actually verify.
7-day trial · no credit card · cancel anytime