Robert Saiz

About Robert Saiz

Technical/Clinical/Regulatory advising consultant focused on medical devices, companion diagnostics, and IVD assay/product development in addition to project management activities related to complex multi-pronged submissions. Primary focus on healthcare associated infections, women’s health, drug screening, and infectious disease diagnostics, with regulatory experience (US, CE-IVD and Health Canada).Experienced Regulatory, Clinical, and Technical consulting lead in multiple large global, mid-size and start-up companies in pre-IDE, 510(k), CE Marking, Clinical Study Proposals and IRB submissions. Ten years’ demonstrated leadership experience in IVDs for assay platform development, technology development of various platforms for target gene detection, gene expression analysis, Real-Time PCR assay design, chemiluminescent, and immunochromatographic assays. Extensive knowledge of multiple manual and automated platforms, systems integration, detection and analysis methods. Exceptional organization and communication skills coupled with a “take-charge” professional mindset ensuring that all projects/studies are taken from concept to full completion.Specialties: Clinical Protocols, Regulatory Affairs for Medical Devices, Pre-IDE Submissions, Domestic (510(k)/PMA) and international (CE Technical File and Design Dossier) for IVD submissions, Process Development, Technology Platform Development, Assay Design/Qualification/Validation, Product Development, Nucleic Acid Testing/Technologies.

Experience

1. Global Head of Diagnostics - Portfolio Strategy for Ivds Devices & Regulatory Affairs

   BioNTech SE

   Apr 2023 — Present · US

   Head of BioNTech Diagnostics Division located in Mainz, Germany. Responsible for Global Product Development and Regulatory strategy to enable the use of IVDs, Companion Diagnostics (CDx), and Medical Devices in all phases of the clinical development pipeline. Primary focus on precision medicine and vaccines in oncology. Global Regulatory and market entry strategy for US, EU (IVDR focus) and ROW.

Education

• San Diego State University

  Bachelor's of Science Degree, Cell/Cellular and Molecular Biology

  1991 — 1994

• UC San Diego

  Masters of Advanced Studies (MAS), Clinical Research

  2010 — 2011

• Regulatory Affairs Profesional Society

  Regulatory Affairs Certificate: Medical Devices, Emphasis: Asia, Canada, Europe, and US Regulations

• UC San Diego

  Regulatory Affairs for the Biomedical Industry Certificate, Regulatory Affairs

  2012 — 2012

Skills

• Molecular Biology
• Genotyping
• Process Simulation
• Pcr
• Glp
• Dna
• Standard Operating Procedure (Sop)
• R&D
• Life Sciences
• Gmp
• Real-Time Polymerase Chain Reaction (Qpcr)
• Elisa
• Cell Culture
• Product Development
• Technology Transfer
• Validation
• Biochemistry
• Genetics
• Qpcr
• Good Laboratory Practice (Glp)
• Pharmaceutical Industry
• Sop
• Fda
• Design Control
• Polymerase Chain Reaction (Pcr)
• Medical Diagnostics
• Microbiology
• Hardware Diagnostics
• In Vitro
• Medical Devices
• Laboratory
• Biopharmaceuticals
• Infectious Diseases
• Genomics
• Molecular Diagnostics
• Biotechnology
• Research and Development (R&D)
• Real-Time Pcr
• Assay Development
• Regulatory Affairs