Winston Salem, NC November 1, 2024 – Rives Consult is pleased to announce that Azita Hedayati has joined the team as Director of Regulatory Affairs. Azita brings a wealth of experience in quality assurance, regulatory affairs, and program management, having spent over two decades in leadership roles within the medical device and healthcare sectors.
Most recently, Azita served as the Sr. Quality Systems Program Manager at Medtronic, where she managed quality initiatives at the Northridge facility. Prior to that, she was the Sr. Director of Regulatory Affairs and Quality Assurance at eVent Medical, overseeing regulatory and quality compliance for medical products at the company’s Lake Forest office.
Azita’s extensive career includes her 9-year tenure at HORIBA Medical as Director of Quality and Regulatory, where she led quality system improvements and regulatory compliance efforts across product lines. She also spent more than 20 years at Beckman Coulter, where she held multiple roles, including Staff QA Scientist and Quality Manager. There, she was responsible for maintaining quality training programs, leading internal audits, and managing a team to ensure compliance with ISO and GMP standards.
Azita's expertise spans quality assurance, product development, and risk management, as well as regulatory compliance. Her hands-on leadership in managing large-scale quality systems, along with her certifications in Clinical Chemistry (ASCP), Certified Manager of Quality/Organizational Excellence (CMQ/OE), and Certified Quality Auditor (CQA), make her a key player in ensuring the knowledge required to move early stage companies forward in all aspects of regulatory compliance and filings.
She holds a Master of Science in Clinical Chemistry from Florida International University and a Bachelor of Science in Chemistry from Florida Agricultural and Mechanical University. Azita is also a patent holder for innovations in DNA separation electrophoresis, reflecting her background in scientific research and product development.
“We are thrilled to welcome Azita to our leadership team,” said Rives Bird, President of Rives Consult “Her deep expertise in regulatory affairs will be instrumental as we continue to enhance our ability to serve our customers’ needs.
For more information, please contact:
Rives Bird
President
Rives Consult