Innovative Health LLC
Scottsdale, AZ, USA
The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies. Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product; Provides documentation and support for the submission/maintenance of regulatory documents for international regulatory bodies; Acts as the liaison between Innovative Health, the FDA and other international regulatory bodies; Reviews complaints/adverse events for submission of MDRs; 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; Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects; Provide regulatory...