Regulatory Consulting Careers in Escondido, CA

Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including: Regulatory Submissions FDA Establishment Registration and Listing US Agent for Foreign Manufacturers Premarket Notification 510(k) Investigational Device Exemptions (IDE) Premarket Approval Submissions (PMA) Technical File/Design Dossier for CE Marking (MDD and IVDD) Health Canada Licenses Foreign country regulatory submission FDA and ISO Quality Systems Requirements Quality system audit Quality procedure review and gap assessments Labeling review and gap assessments Design control protocols and report We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion. Visit the Services link to fin