Maria Alexandra P.Private profile: Upwork shows its earnings only to signed-in members, so we check it every few weeks, not daily. MRR here is a rough estimate (Upwork's six-month earnings ÷ months active). Last read Nov 5, 2026.

I am an experienced Quality and Regulatory Affairs Consultant and have experience with various medical devices. I have a Master's Degree in Artificial Intelligence and a Bachelor's Degree in Biomedical Engineering. I have experience working with medical device regulations (MDR, ISO 13485, FDA QSR 21 CFR Part 820). I am committed to compiling complete submissions for improved clearance times, leading to faster time to market. My skills cover the following activities: • Establishing and maintaining a Quality Management System complaint with ISO 13485 and Medical Device Regulation • Performing ISO 13485 internal audits, supporting the audited team in external audits and supplier audits. • Setting up and preparing all technical documentation needed for CE mark/510(k) submissions • Management of non-conformities, complaints and corrective and preventive actions requests. • Identifying the applicable test requirements (ISO standards, etc.) • Predicate device comparisons • Supplier management • Experience with JIRA, Confluence, eQMS, QCBD • Familiar with TGA regulatory documents (Therapeutic Good Act, Therapeutic Good Regulation) • Work together with product development team to compile the Technical Documentation as required by the MDR • Labeling and packaging • Literature research • Contacting and handling subsequent follow-ups and questions from Notified Bodies • MDSAP submission Systems: Quality Management System, Medical Device Management System, Regulatory Requirements, CE marking - Technical documentation. Qualification: Certified internal auditor for ISO 13485. Other areas of expertise: - Wordpress developer and designer - Photo and video editor - Python developer (data analysis, machine learning) - Matlab developer (signal and image processing, CNN, computer vision) - Skilled in AutoCAD I am fast-working, but very accurate, and I pay very big attention to deliver my work in time and exactly up to your requirements. Looking forward to working with you!