Description
My client will be looking for consultants with experience in the following:-Authored U.S. and EU submissions including 510(k)s, Technical Files/ Design Dossiers for a hardware and/or disposable Class I, II and III devices
- PMA experience along with IDE, feasibility study and pivotal study experience
-Extensive experience interacting with FDA, Notified Bodies and other international organizations during and in preparation for audits, submissions, meetings, registration and import/ export matters
-In-depth understanding and knowledge of Quality System Regulations (QSRs), Design Controls, Regulatory Submission Strategies, Pre and Post Market Regulatory Requirements, Risk Analysis (ISO 14971), CAPAs and Change Control
-Excellent leadership and project management skills as well as the ability to meet deadlines and support multiple concurrent projects
-Regulatory Affairs Certified (RAC), Lead Auditor ISO 13485 Certified, Fundamentals of Engineering (FE) Certification