Joseph R. Tamayo
Regulatory, Quality and Clinical. Class III Implantables, Combination Technologies, Med Device, Biotech
- Role
- Vice President of Regulatory and Quality at Theradaptive
- Location
- Santa Rosa, CA, US
- LinkedIn followers
- 500 followers
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.
Experience
Vice President of Regulatory and Quality
Apr 2023 — Present
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
Loyola Marymount University
Bachelor of Science, Biological Sciences
Skills
- Qsr
- Clinical Study Design
- Product Launch
- Medical Devices
- Clinical Research
- Capa
- Iso 14971
- Complaint Management
- 21 Cfr Part 11
- Executive Management
- Regulatory Affairs
- Clinical
- Ectd
- Complaint Handling
- Quality System
- Quality Systems
- V&V
- Biotechnology
- Ce Marking
- Pharmaceuticals
- Ind
- Pharmaceutical Industry
- Clinical Development
- Fda
- Quality Control
- Gmp
- Start-Up Environments
- Strategy
- Regulatory Submissions
- 510 K
- R&D
- Regulatory Strategy
- Quality Assurance
- Pma
- Iso 13485
- Ide
- Design Control
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