Steven Ziemba

About Steven Ziemba

Over 25-years of experience in USA and OUSA regulatory affairs, clinical study development and management of GMP/ISO compliant quality systems for Class medical devices. Experience in clinical study protocol and informed consent development, management and completion of small (500 subjects) human clinical studies at U.S. & international sites for 510(k) & PMA approval and CE Marking. Successfully drafted and prosecuted IDEs and 10 original PMAs, numerous supplements and 510ks, as well as >15 CE Technical File/Design Dossiers with 8 different Notified Bodies. Prosecuted marketing approvals from Health Canada, TGA, PMDA, SAHPRA, KFDA, ANVISA, Cofepris, MHRA and OFAC. Have managed numerous meetings with FDA and NBs to set and review strategies including IDE protocol development, FDA Panel meetings, Q-Subs, SIRs, Clinical Evaluation Reports, recall planning, AIP and issue remediation. Expert at managing US-GMP and ISO 13485:2016 compliance inspections, including FDA and NB pre-approval inspections, certification audits and routine surveillance after approvals. Have lead teams that successfully completed ISO and GMP compliance audits at in-house and CMO locations in USA, Switzerland, Japan, Singapore and Mexico. Strong believer that management of regulatory, clinical and quality systems should be visible and support the entire organization by providing confidence-in-compliance and on-time completion. This is achieved by providing clear summaries of useful system metrics and data, including complaints, MDRs, etc, and leading teams to integrate clinical/regulatory and quality system planning and feedback into operational and corporate management systems. Experience also includes direct involvement in statistical planning and test development for ISO-14971 risk management/reduction planning, product design and process validation/verification, specification development, Human Factors evaluations, sterilization process and endotoxin testing validation, in-vitro and in-vivo biocompatibility studies. Significant expertise in ophthalmic medical devices with experience as well in general surgery, orthopedic and dental devices/pharms. Served as CEO of U.S. Operations and V.P. of Global Regulatory/Clinical Affairs/QA at Hoya Surgical Optics and Sonendo Inc,as well as corporate officer at Altaviz, Synergeyes and Staar Surgical.

Experience

1. Principal Consultant for Quality Systems, Regulatory and Clinical Affairs

   Ingenarious Consultants

   Feb 2020 — Present · Tustin, CA, US

   Design development to product approval, our seasoned professionals can help at all levels of quality system development, regulatory compliance (ISO/FDA) and clinical research (protocols to FDA/CE filings).

Education

• University of Southern California

  M. Sc.

  1985 — 1987

• California State University, Long Beach

  B.A., Biology

  1975 — 1980

Skills

• Product Launch
• Clinical Trials
• Budgets
• Surgery
• Project Management
• Healthcare
• Medical Devices
• Clinical Research
• Cross-Functional Team Leadership
• Capa
• Sales Management
• Quality System
• Biotechnology
• Process Improvement
• Leadership
• Iso 13485
• Regulatory Affairs
• Management
• Regulations
• Fda
• Product Development
• Training
• Quality Assurance