Joseph R. Tamayo

Vice President of Regulatory and Quality @Theradaptive

Santa Rosa, CA, US
MOBILE NUMBERS
+17•••••••46

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WORK HISTORY

Apr 2023 — Present

Vice President of Regulatory and Quality @Theradaptive

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Recombinant proteins engineered into material-binding variants that can be used to coat implants, devices, and injectable carriers for precision therapeutic delivery.Spinal fusion and orthopedics, soft tissue repair and targeted chemotherapeutics.Class Combination Technologies

EDUCATION

N/A

Loyola Marymount University

Bachelor of Science, Biological Sciences

SKILLS

QsrClinical Study DesignProduct LaunchMedical DevicesClinical ResearchCapaIso 14971Complaint Management21 Cfr Part 11Executive ManagementRegulatory AffairsClinicalEctdComplaint HandlingQuality SystemQuality SystemsV&VBiotechnologyCe MarkingPharmaceuticalsIndPharmaceutical IndustryClinical DevelopmentFdaQuality ControlGmpStart-Up EnvironmentsStrategyRegulatory Submissions510 KR&DRegulatory StrategyQuality AssurancePmaIso 13485IdeDesign Control

ABOUT JOSEPH R. TAMAYO

Innovative management professional with over twenty-five years of industry experience. Diverse regulatory experience in medical devices, biologics, and drugs. Broad scoped background in class implantable devices. Regulatory and quality support for all phases of international and domestic product “concept to market” life cycle. Specializes in combination technologies. Strategic regulatory and quality management planning and team based program management. Virtual quality systems. Quality Management Representative. Served on a number of executive management teams in a regulatory, quality, clinical and operations capacity. Product launch. Virtual start-ups, start-ups, small business units, medium sized to large scale corporate environments. Experience in business operations, including supply chain management, material flow and production ramp up.Specialties: Hybrid/ combination medical products, class implantable medical device products, cardiovascular technologies, executive management, regulatory strategy, quality management representative, quality systems, Design Dossier, Technical Files, PMA, IDE, 510(k), hybrid regulatory submissions, clinical feasibility trials, start-up environments.

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