The Catalyst Group has been tasked by a growing medical device client to identify and evaluate a regulatory affairs professional for a newly created position. This position and given responsibilities will be tailored to an individuals level of experience and will be responsible for determining appropriate regulatory requirements and strategies for the release of new and/or modified medical devices. This will include preparing and submitting all required documentation of all pre-market notifications (eg. applications to the FDA for marketing of new/modified medical devices, PMA, 510(k)’s, etc.). and assisting in the development of product labeling instructions and promotional materials and review labeling/advertising for compliance with medical device regulations. This position will also participate in new product development teams to provide direction with respect to regulatory requirements while determining and preparing appropriate international filings and registrations.

Required B.S. degree in Life Science. 2+ years relevant experience including submission of IDE’s, PMA and 510(k) documents. Knowledge of biostatistics and computer database development.

Greg Giltner, Sr. Recruiter
greg@catgroupinc.com
803-223-9126
http://www.linkedin.com/in/giltner