Danbury, CT 06810
Regulatory Affairs Specialist
Must have Medical Device background. Regulatory Affairs Specialist will be responsible for international regulatory activities associated with Notified Body in EU, and other international regulatory agencies.
Prepare, compile and publish electronic pre-market and post-market regulatory submissions Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark
Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance.
Develop and/or revise regulatory procedures
Bachelor's Degree required in the life sciences or engineering with a minimum of 3 years direct experience in Regulatory Affairs (within an IVD industry preferred).
Solid working knowledge of the US Regulations and European IVD and medical device directives Material handling or ability to learn forklift operations
Experience with International submissions and IVDs highly desirable
Since 1984, The Reserves Network continues to partner with the finest employers to provide opportunities within the office, industrial, professional and technical markets. As a family- and veteran-owned company, we focus on candidate experience and workplace culture for the nearly 20,000 employees we place annually.
For more information contact Lisa at 203-651-6616
If interested, please send a resume to email@example.com