Pablo Ojeda

Pablo Ojeda Email and Phone Number

Medical Devices QA/RA Specialist | Enhancing Quality and Compliance through R&D and Innovation @ RegDesk
philadelphia, pennsylvania, united states
Pablo Ojeda's Location
General Roca, Río Negro Province, Argentina, Argentina
Pablo Ojeda's Contact Details

Pablo Ojeda personal email

About Pablo Ojeda

With over 20 years of experience in regulatory affairs and quality management in medical devices, my career has been a journey of continuous evolution from quality engineering beginnings to leadership roles in technical and regulatory areas. Specialized in Bioengineering and with a solid foundation in Quality Engineering from the Universidad Tecnológica Nacional (UTN), my focus has always been on innovation and excellence in the development, manufacturing, and certification of medical devices, with a particular emphasis on dental and vascular implants.My role as a consultant and leader in various organizations has been crucial for the implementation of quality management systems and effective regulatory strategies, ensuring compliance with international standards and optimizing processes for product improvement. I am a solution-oriented engineer with a unique ability to organize resources and lead teams to success in complex and regulated environments.Beyond my technical profile, I consider myself a person with exceptional human relations skills and a deep commitment to staff empowerment. As a husband and father, I value the importance of relationships and the balance between personal and professional life, firmly believing that success is built on the foundation of one's own happiness and well-being and that of those around us.Specialties: Quality Engineering, Research and Development of Medical Devices, Regulatory Affairs in Medical Devices.

Pablo Ojeda's Current Company Details
RegDesk

Regdesk

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Medical Devices QA/RA Specialist | Enhancing Quality and Compliance through R&D and Innovation
philadelphia, pennsylvania, united states
Website:
regdesk.co
Employees:
19
Pablo Ojeda Work Experience Details
  • Regdesk
    Senior Regulatory Affairs Specialist
    Regdesk Feb 2023 - Present
    Estados Unidos
  • Freelance
    Medical Devices R&D Consultant
    Freelance Jan 2023 - Present
  • Cormedic S.A. | Sveltia
    Product Engineering Manager
    Cormedic S.A. | Sveltia Feb 2021 - Jan 2023
    Cordoba, Argentina
  • Cormedic S.A. | Sveltia
    Quality Management Specialist
    Cormedic S.A. | Sveltia Aug 2017 - Jan 2023
    Córdoba Province, Argentina
  • Cormedic S.A. | Sveltia
    Product Manager
    Cormedic S.A. | Sveltia Feb 2018 - Feb 2021
  • Latecba
    Operations Manager
    Latecba Jul 2011 - Jul 2017
    Buenos Aires, Argentina
    Planning and Control of ProductionISO 13485:2003 Quality Management SystemRegulatory Affairs Internal AdvisorCAPA Plan and Non Conformance Products EvaluationDesign and Development Assitant
  • Trust Technology
    Technical Director & Ra Manager
    Trust Technology Mar 2009 - Jun 2011
    Regulatory Affairs management of Medical Devices.Products registration, competent authorities communications, GMPs, ISO 13485, ISO 9001, MDD 93/42/EEC, etc.
  • Medes Argentina Srl
    Project Leader
    Medes Argentina Srl Oct 2005 - Mar 2009
    Quality Management System and Regulatory Affairs Consulting for Medical Devices Manufacturers.ISO 13485, ISO 9001, MDD 93/42/EEC, ISO 14971
  • Bioingenieria Uner
    Research Laboratory Assistant
    Bioingenieria Uner 2004 - 2005
    Bioelectricity Lab (FIUNER)

Pablo Ojeda Skills

Quality Management R Iso 14971 Ce Technical Files 2003 Lead Auditor Aseguramiento De La Calidad Gmp Biomedical Engineering Fda 510k Regulatory Affairs English Iso 9000 Medical Devices Strategic Planning Quality System Liderazgo De Equipos Microsoft Office Liderazgo Microsoft Excel Manufacturing 2003 Lead Quality Control Capa Implants Iso 17025 Fda R&d Bioengineering Iso 13485

Pablo Ojeda Education Details

Frequently Asked Questions about Pablo Ojeda

What company does Pablo Ojeda work for?

Pablo Ojeda works for Regdesk

What is Pablo Ojeda's role at the current company?

Pablo Ojeda's current role is Medical Devices QA/RA Specialist | Enhancing Quality and Compliance through R&D and Innovation.

What is Pablo Ojeda's email address?

Pablo Ojeda's email address is p_****@****ail.com

What schools did Pablo Ojeda attend?

Pablo Ojeda attended Universidad Nacional De Entre Ríos, Universidad Tecnológica Nacional.

What are some of Pablo Ojeda's interests?

Pablo Ojeda has interest in Science And Technology, Education, Health.

What skills is Pablo Ojeda known for?

Pablo Ojeda has skills like Quality Management, R, Iso 14971, Ce Technical Files, 2003 Lead Auditor, Aseguramiento De La Calidad, Gmp, Biomedical Engineering, Fda 510k, Regulatory Affairs, English, Iso 9000.

Who are Pablo Ojeda's colleagues?

Pablo Ojeda's colleagues are Eliseo Angulo Viurcos, Viktorija Georgieva, Matt Winters, Liu Bing, Serhii Voloshyn, John Adler, Inna Yesina.

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