Dessi Lyakov

About Dessi Lyakov

Regulatory Affairs and Quality leader with over 20 years of experience in a fast-paced IVD and Medical Device manufacturing environment. Experience with 510(k) submissions, CE marking, design control, validations, risk management, UDI, internal, external, and supplier audits, FDA inspections, ISO audits, supplier management, complaint management, CAPA, and other regulatory and quality activities. Direct interaction with the FDA, Notified bodies, and other national and international regulatory agencies.

Experience

1. Director Quality and Regulatory Affairs

   Clinicomp

   Aug 2019 — Present · San Diego, CA, US

   Coach and mentor Quality and Regulatory employees ensuring appropriate levels of accountability for decision making and clear cross-functional communication within the organization.Develop and implement regulatory strategies and processes to gain product clearance with the FDA.Provide training and interpretation of FDA and other regulatory requirements and support of the quality system with effective leadership support, training, and guidance to all company personnel.Oversee preparation and filing of all regulatory documents with the FDA.Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events. Responsible for the company\'s Quality Compliance with regulatory agencies.Develop and execute regulatory and quality strategy for new product development and sustaining business activities.Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.Oversee CliniComp’s training program and Supplier Management system.Conduct internal and external audits.Management Representative for CliniComp.HIPAA Officer for CliniComp.

Education

• University of Chemical Technology and Metallurgy, Sofia, Bulgaria

  Master’s Degree, Chemical Engineering

Skills

• Quality Assurance
• Regulatory Affairs
• Quality Control
• Gmp
• Standard Operating Procedure (Sop)
• Medical Devices
• Capa
• Sop
• Fda
• Quality System
• Design Control
• Validation
• Corrective and Preventive Action (Capa)
• R&D
• U.s. Food and Drug Administration (Fda)