Regulatory Affairs Expert at People Connect Staffing
Posted in General Business 30+ days ago.
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Location: San Francisco, California
Job Title: Regulatory Officer
Location: Emeryville, CA
This is a nation-wide search
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.
- Standard medical benefits
- Competitive salary
- Relocation assistance if needed