Emmanuel Nyakako
About Emmanuel Nyakako
Emmanuel Nyakako serves as the Senior Vice President of Quality and Regulatory Affairs at ConforMIS, Inc., where he has worked since 2017. He possesses extensive experience in managing FDA-regulated products and has held various leadership roles in quality and regulatory affairs across multiple organizations.
Current Role at ConforMIS
Emmanuel Nyakako serves as the Senior Vice President of Quality and Regulatory Affairs at ConforMIS, Inc. since 2017. In this role, he is responsible for overseeing quality assurance and regulatory compliance within the organization. His leadership contributes to the effective management of FDA-regulated products, ensuring adherence to industry standards and regulations. Nyakako's position is based in the Greater Boston Area, where he applies his extensive experience in regulatory affairs to enhance the company's operational effectiveness.
Education and Expertise
Emmanuel Nyakako holds a Master of Science degree from Montclair State University, which he completed between 1994 and 1997. He also earned a Bachelor of Science degree from Ramapo College of New Jersey from 1986 to 1990. His educational background supports his expertise in quality and regulatory affairs, particularly in managing compliance and regulatory submissions, including 510K and PMA processes.
Professional Background
Emmanuel Nyakako has a diverse professional background with significant experience in quality and regulatory affairs. He has held various leadership roles, including Senior Compliance Specialist at Ethicon Endo-Surgery and Corporate Director of QA/RA at Nypro, Inc. He also served as Vice President of Global Quality and Regulatory at Flextronics and as Senior Vice President of Global Quality, Clinical, and Regulatory Affairs at Zimmer Holding Inc. His career spans both public and private sectors, including start-ups and international companies.
Regulatory Affairs Experience
Nyakako has extensive experience in managing regulatory affairs, including interactions with the FDA's Center and District branches. He has effectively managed compliance remediation activities and resolved FDA warning letters and Form 483 issues. His expertise includes designing and implementing quality management systems across various business environments, ensuring compliance with regulatory standards.
Career Achievements
Throughout his career, Emmanuel Nyakako has demonstrated a commitment to quality and regulatory excellence. His roles have involved significant responsibilities in managing FDA and other regulated products. He has successfully overseen compliance activities and regulatory submissions, contributing to the operational success of the organizations he has worked with. His leadership in quality management systems has been instrumental in enhancing compliance across different business sectors.