Senior Regulatory Affairs Specialist

Role Overview

• Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets.
• Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies.
• Partner with Marketing and Development teams to provide support to currently-marketed products as necessary.
• Compile and submit documentation as required in support of marketing initiatives.
• Review marketing and sales promotional materials for regulatory impact, including: Promotional materials for journals and other media, Trade show booths, materials for distribution, Sales talking points, etc.
• Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion.

Requirements

• B.S. / B.A. or equivalent combination of education and experience.
• 5+ years of regulatory medical device industry experience.
• RAC Certification preferred.
• Knowledge of regulatory guidelines and requirements (domestic and international).

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs