Senior International Regulatory Affairs Specialist

Working closely with the Senior International Regulatory Affairs Manager, the International Regulatory Affairs Specialist will be responsible for supporting international regulatory affairs registrations on medical devices and in vitro diagnostic devices across the globe.

Requirements

• B.S. degree or higher in a technical discipline
• 4- 9 years Regulatory Affairs experience in medical device companies
• Working knowledge of 510(k), MDD 93/42/EEC, MDR 2017/745, and 21 CFR 820 -Quality System
• Proficient in using Microsoft Word, Excel, and PowerPoint
• Proficient in English
• Strong communication Skill, both oral and written
• Strong project management skills