Jessica Piovarcsik

Quality and Regulatory consulting in the Medical Device sector.

· Acts as an RA/QA representative in interdepartmental team meetings providing guidance on compliance with the Quality System, design controls, risk management, regulatory strategy, biocompatibility, sterilization, standards, and domestic/international regulations. · Review of technical, DHF, and risk management documentation such as human factors analyses, hazard analyses, clinical evaluations, substantial equivalence testing protocols and reports, nonconformance reports, temporary deviation orders, and post market clinical follow-up plans. · Extensive registration and change management experience in the USA, EU, Canada, and Latin American markets. Moderate experience in South Korea, Australia, New Zealand, and MENAT (Middle East, North Africa, Turkey) markets. · Review/approve domestic and international product labeling, instructions for use, and promotional materials. · Managed, authored, reviewed or provided mentorship in 20 FDA 510k clearances · Thorough understanding of 21 CFR 820, medical device manufacturing and ISO/EC (MDD, MDR, CMDR, ISO 13485) requirements. · Managed enterprise level projects, including MDSAP, UDI, and ISO 10993 upgrade implementation. · Oversaw the biological sciences department responsible for biocompatibility, bioburden, and sterilization testing and strategy. Guided teams on navigating biological risk assessments. (2014-2021) · Leads discussions and manage support teams during on site Quality System audits by regulatory agencies and customers. · Decision-maker for product disposition, CAPAs, and other scenarios navigating product, patient, and business risk

Responsibilities include, but are not limited to: Performing the initial step of antibody purification by altering protein solubility followed by differential centrifugation; training new laboratory assistants; preparation of SDS-PAGE gels, ELISA plates and various reagents and buffer solutions; labeling and aliquoting final antibody products; reconstituting frozen antibodies; data entry. Achievements include: An integral part in incorporating the barcode labeling system company-wide; improving speed and efficiency in the lab by amending the company protocols

Biological Sciences/Physiology Consultant QL+ Project #37a1 - Wheelchair door keeper Biodigester Cooking Stove project for Guatemala

4 years laboratory experience during undergraduate work