Innovative Health LLC

The Sr. Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for the submission of FDA 510(k)s, periodic updates, Canadian applications and registrations to regulatory agencies. Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product. Responsible for preparing Canadian applications to obtain approval to commercially distribute product. Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information. Prepare routine regulatory correspondence and assure submission to government agencies in support of marketed products. Participate in project development teams and review plans, reports, risk management, and design reviews associated with product and process projects. Assess necessity for submitting a 510(k) application by preparing...