The Catalyst Group www.catgroupinc.com has been tasked by a growing medical device client to identify and evaluate a Regulatory Affairs professional. The successful candidate will be responsible for supporting existing medical products as well as on-time introduction of new products. This will include preparing and submitting FDA applications (510K, PME, etc.), coordinating FDA submission review, international applications, assisting with pre-clinical planning and clinical proposal review, new product labeling and instructions, etc.

Basic Qualifications: B.S. degree (NO EXCEPTIONS); 1-5 years experience in a Medical Device regulatory capacity (IDE, PMA, 510(k)’s, and CE mark technical file submissions); Domestic and European medical regulation experience. Willingness and desire to travel.

Preferred Qualifications: MS degree; professional certifications; strengths in technical writing and analytical thinking; strong communicator; technical aptitude with information systems, statistics, etc.

They offer an attractive base salary, annual bonuses, outstanding benefits, and unlimited growth potential.

To apply for this position, please reference position title and location in an e-mail along with resume and most current salary information to greg@catgroupinc.com

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