Regulatory Affairs Specialist I

Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents). Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required. Provide technical collaborate with FDA and international reviewers and respond to questions. Provide timely review and approval of product labeling and marketing claims for regulatory compliance. Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations