I have been working for 2.5 years with NeuMoDx/Qiagen in Ann Arbor, MI as a Regulatory Affairs Manager, responsible for IVDD and IVDR devices Class A, B, C and D.I have been preparing, reviewing and compiling all necessary documents for submission to the Notified Body to get CE marking approval. I led interactions and communications with Notified Body (BSI) throughout the submission review period until it was successfully approved.I represented Regulatory Affairs in cross functional teams comprised of R&D, Clinical and Medical Affairs, Sales and Marketing, Quality and labeling providing advice and insight into new regulatory requirements, applicable and harmonized standards such as ISO 13485, ISO 14971 …etc in order to mitigate any risks and comply with all the necessary requirements in timely fashion including General Safety and Performance Requirements (GSPRs) , Common Specifications, IFUs, SDSs and labels, Performance Characteristics…etc.I participated in Phase 3 and 4 Design Review and Design lock meetings, reviewing all required design outputs such as risk management files, summary of safety and performance (SSP), verification and validation protocols and reports, post market surveillance plans (PMS), analytical and clinical performance and stability studies. I was also involved in a Clinical Trial Presub. to the FDA and a 510K for a Class II device. I have attended two MDSAP audits of our facility in Ann Arbor, MI.Prior to joining Qiagen, I worked for 1 year as Regulatory Consultant with a Florida (Miami) based company (Curallux) manufacturing Laser operated medical devices. I was running post marketing patient experience program for the company’s laser devices (Laser caps and laser belts).I had more than 15 years of experience in the pharma market (Rx and generic) working as Regulatory Affairs professional in different parts of the world
Listed skills include Validation, Regulatory Submissions, Sop, Fda, and 4 others.
