Our client is a VC, industry, and government funded Robotics Company who is searching for a Regulatory Expert. They are bringing advanced accessible exoskeletons to industrial and medical markets. Our client was chosen as one of the top 50 leading companies of 2017
What you will do as a Regulatory Officer:
Respond to inquiries from regulatory bodies as required
Communication with FDA
Prepare and submit FDA 510(k) applications
Prepare different elements of design, quality, and risk documents for a class II medical device
You MUST have to be successful in this role:
Extensive experience in regulatory affairs and the medical device industry
Hands on experience prepare and submit materials for 510(k) and CE Mark.
Direct experience with FDA QSR and ISO 13485
Ability to pay attention to details on documents submitted as a part of 510(k) application.
Proficient in using Microsoft Office and other office software
Bachelors or advanced degree
Direct experience with China FDA is a plus
This position will report directly to the CEO of the company.