Petrona McArthur has over thirty years of experience in Quality Assurance and Regulatory Affairs in the medical field, with a wide range of devices including cardiovascular, cardiopulmonary, surgical, orthopedic, urological, dental and tissue products.
Before joining A&M; Biomedical, Petrona was RA/QA Manager at Passy-Muir, Inc., a company distributing speaking valves for tracheostomies and ventilator-dependent patients. Prior to Passy-Muir, Petrona held various quality and regulatory positions for companies such as Isotis/GenSci OrthoBiologics, Inc. (now Integra Life Sciences), Trimedyne Inc., Advanced Interventional Systems (now known as Spectranetics), and Shiley Inc. (a division of Pfizer).
Petrona’s previous experience includes implementing and maintaining quality systems, in compliance with FDA regulations and international standards, as well as document control, complaint handling, filing medical device reports, vigilance reporting, inspections, and product recalls. She also participated in the OCRA MDR Network Group, a recipient of the National Performance Review Hammer Award from Al Gore Hammer in 1999, for their collaboration with FDA on patient safety. Petrona has been a Network Group Member of OCRA MDR since April 1996 and an OCRA member since 1992.
Petrona McArthur has over thirty years of experience in Quality Assurance and Regulatory Affairs in the medical field, with a wide range of devices including cardiovascular, cardiopulmonary, surgical, orthopedic, urological, dental and tissue products.
Before joining A&M; Biomedical, Petrona was RA/QA Manager at Passy-Muir, Inc., a company distributing speaking valves for tracheostomies and ventilator-dependent patients. Prior to Passy-Muir, Petrona held various quality and regulatory positions for companies such as Isotis/GenSci OrthoBiologics, Inc. (now Integra Life Sciences), Trimedyne Inc., Advanced Interventional Systems (now known as Spectranetics), and Shiley Inc. (a division of Pfizer).
Petrona’s previous experience includes implementing and maintaining quality systems, in compliance with FDA regulations and international standards, as well as document control, complaint handling, filing medical device reports, vigilance reporting, inspections, and product recalls. She also participated in the OCRA MDR Network Group, a recipient of the National Performance Review Hammer Award from Al Gore Hammer in 1999, for their collaboration with FDA on patient safety. Petrona has been a Network Group Member of OCRA MDR since April 1996 and an OCRA member since 1992.
Biography
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