Patrice JC Nedelec 🇺🇦 🇺🇸🇫🇷

Patrice JC Nedelec is an experienced healthcare quality management executive with a strong focus on regulatory affairs. They have held various leadership roles throughout their career, working for companies such as Sirona Medical, GLG, Ambra Health, Greenway Health, SCC Soft Computer, Fluke Corporation, lifeIMAGE, Sunquest Information Systems, and Merge Healthcare.

In their most recent position as Vice-President of Quality Management and Regulatory Affairs at Sirona Medical, Patrice is responsible for re-founding and implementing quality and regulatory practices, as well as implementing lean management principles.

Prior to that, they worked as a Council Member at GLG, where they provided consultancy services in quality management, regulatory affairs, compliance, and client services.

At Ambra Health, where they served as the Head of Quality, Regulatory Affairs, and Compliance, Patrice led the development and execution of a lean and growth-focused quality management system. They were also actively involved in pre-sales activities, regulatory affairs, risk management practices, and implementing global standards.

In their role as Vice-President of Quality Assurance, Regulatory Affairs, and Compliance at Greenway Health, Patrice oversaw the company's quality assurance, regulatory affairs, and compliance functions.

During their tenure at SCC Soft Computer, Patrice held the position of Vice-President of Client Services, Quality, Regulatory Affairs, and Education. They focused on turnaround initiatives, such as client retention, quality and regulatory affairs improvement, and leadership and oversight of major suppliers.

At Fluke Corporation, Patrice served as the Executive Leader of Quality and Regulatory Affairs, where they successfully led the turnaround of FDA compliance within a 5-month period.

In their earlier career, Patrice held senior executive positions at lifeIMAGE, Sunquest Information Systems, and Merge Healthcare. They were responsible for quality, regulatory affairs, client support, and program management.

Overall, Patrice has a comprehensive background in healthcare quality management, regulatory affairs, and client services, with a proven track record of successfully implementing and improving quality systems, regulatory compliance, and customer satisfaction.

Patrice JC Nedelec 🇺🇦 🇺🇸🇫🇷 began their education at EPITA: Ecole d'Ingénieurs en Informatique, where they pursued a degree in Engineering with a focus on Networks and Software Development. They attended this institution from 1986 to 1989. After that, they went on to pursue a Master of Science - MS in Computer Software Engineering at IMT Atlantique from 1990 to 1991.

In addition to their formal education, Patrice JC Nedelec 🇺🇦 🇺🇸🇫🇷 obtained several certifications. These include the Certified lean management specialized credential candidate from ASQ - World Headquarters in August 2021, ISO 9001 Lead Auditor certifications from Exemplar Global, Inc. in May 2018, AAMI Quality System FDA and ISO 13485 certifications from AAMI in April 2018, Certified Agile Leader 1 from Scrum Alliance in November 2016, 4DX Manager and Leader Certification (4 Disciplines of Execution) from FranklinCovey in May 2013, Certified Biomedical Auditor from ASQ in June 2006, Certified Manager of Quality - Organizational Excellence from ASQ in March 2007, Certified Quality Auditor from ASQ in August 2003, Certified Supplier Quality Professional from ASQ - World Headquarters in November 2019, and Certified Scrum Master (Agile) and Certified Scrum Product Owner (Agile) from Scrum Alliance in March 2015.