Randy Vader Email & Phone Number

Highly effective business executive with over 20 years of experience in all aspects of Global Regulatory Affairs, Quality Management Systems, Quality Assurance, Clinical Affairs and Corporate Compliance for Medical Device companies. My focus is on business growth, business revenue growth, business efficiency, cost reduction and risk based compliance. I have superb relationships with the U.S. FDA and all Global Regulatory Bodies.Areas of Expertise:1. U.S. FDA Regulatory Submissions and Approvals (IDE, 510(k), PMA, CDx, BLA, IND, ANDA, NDA, etc.).2. Global Regulatory Submissions and Approvals (U.S., Canada, China, Japan, EU, EMEA, LATAM, etc.).3. Global Regulatory Requirements (U.S. FDA QSR, GMP, 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807, ISO 13485, ISO 9001, ISO 14971, IEC 62304, IEC 60601, ISO 14155, ISO 15189, ISO 10993, MDD 93/42/EEC, IVDD 98/79/EC, cGMP, 21 CFR 210, CLIA, CAP, New York State, etc.).4. Quality Management Systems, Quality Assurance and Quality Control.5. Corporate Compliance (HIPAA, HITECH, DHHS, OIG, Physician Payment Sunshine Act (PPSA), Anti-Kickback, DHS, etc.).6. Good Clinical Practice (GCP), Clinical Affairs, Clinical Studies and Clinical Trials.7. U.S. FDA Warning Letter and U.S. FDA Consent Decree Resolution.8. Global Regulatory Strategies and Global Agency Negotiation.9. Product Categories (Oncology, Cardiology, Orthopedics, Implantable, Interventional, Surgical, Medical Informatics, Medical Imaging, Medical Device, Medical Diagnostics, Medical Device Software, In Vitro Diagnostics, Companion Diagnostics, Biologicals, Tissue, Blood, Pharmaceutical, Combination Products, etc.).10. Product Sterilization (Gamma Irradiation, Ethylene Oxide (EO), E-Beam, Steam, etc.).11. Software Development Life Cycle Processes.12. Product, Process and Equipment Validation (IQ/OQ/PQ).13. Medical Device and Import/Export Law.14. Medical Device Recalls and Corrections & Removals.15. Building World-class teams.16. Aligning Global Regulatory Affairs, Quality Assurance, Clinical Affairs and Corporate Compliance with Business Growth and Profitability.Randy VaderTelephone: (608) 692-7839Email: randyvader@sbcglobal.net

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  San Diego State University

  Bachelor Of Science - Bs