Description
Company is Chicagoland area is looking for a Senior Regulatory Affairs Specialist. This is a great opportunity for a self starter. This company offers great benefits and has a work hard play hard mentality.This company is a global developer, manufacturer and provider of laser, light-based, radiofrequency and ultrasound devices for aesthetic and medical applications. They have been at the forefront of innovative multi-technology/multi-application systems designed to meet the unique needs of today's practitioners
The salary is flexible based on experience but they are paying from 90k-120k.
Essential Skills:
-Bachelors Degree (prefer in Science)
-Established relationships with regulatory authorities (FDA)
-7-10 years regulatory affairs experience
-5+ years medical device background
-510k experience a must (submission with your name on it)
-Expert knowledge of medical device regulations, standards, current industry practices and strong experience with interpretation and application
-Experience with hardware and software of medical devices required
-Software submissions experience
-Proficient in Microsoft Outlook, Microsoft Work and Microsoft Excel
Desirable Skills:
-Experience with medical aesthetic submissions
-Class II submission experience
-Familiar with international regulations (U.S./Canada)
To find out more about Real please visit www.realstaffing.com