Meritxell Martinez
Project Manager and Regulatory Specialist at Innolitics- Claim this Profile
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English Native or bilingual proficiency
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Spanish Native or bilingual proficiency
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French Elementary proficiency
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Experience
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Innolitics
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United States
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Software Development
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1 - 100 Employee
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Project Manager and Regulatory Specialist
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Feb 2023 - Present
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The BME Life
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United States
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Biotechnology
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Co-Founder
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Aug 2018 - Present
The BME Life is a social media platform dedicated to sharing information on biomedical engineering while creating a community of students and industry professionals in the field. Our mission is to inform young minds all around the world on the different industries related to BME by sharing insights into the college experience and industry, as well as having podcasts with industry professionals and engineering students. The BME Life is a social media platform dedicated to sharing information on biomedical engineering while creating a community of students and industry professionals in the field. Our mission is to inform young minds all around the world on the different industries related to BME by sharing insights into the college experience and industry, as well as having podcasts with industry professionals and engineering students.
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Creative Electron, Inc.
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United States
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Appliances, Electrical, and Electronics Manufacturing
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1 - 100 Employee
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Sales Engineer
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Apr 2022 - Feb 2023
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Medical Device Academy, Inc.
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Associate Regulatory Consultant
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Feb 2021 - Apr 2022
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Regulatory Affairs Intern
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Dec 2020 - Feb 2021
Responsible for supporting the efforts in preparing regulatory submissions including Pre-Submission meeting requests, 510(k) submissions, De Novo submissions, Canadian License Applications, and CE Marking applications as needed by clients. Additional responsibilities include updating quality system documentation and participating in teleconference meetings with the FDA.
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Progenerative Medical, Inc.
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Product Development Engineer
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May 2020 - Feb 2021
• Gained foundational knowledge of requirements for Premarket Notification submissions and collaborated in preparing 510(k) for regulatory submission to the FDA• Participated in medical advisory board meetings with orthopedic surgeons for human factors validation testing, Instruction for Use review, and clinical protocol review• Created 10+ testing protocols and reports for Design Verification and Validation including but not limited to simulated use testing, verification testing, validation testing, and user questionnaires following Standard Operating Procedures• Reviewed 220+ Medical Device Reporting records from MAUDE FDA database as part of risk management strategy• Built and tested 700+ negative pressure wound therapy systems for Design Verification and Validation pipeline• Contributed new techniques to solve technical processes and improve existing testing procedures
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Product Development Intern
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Mar 2019 - May 2020
• Execute supporting testing and documentation for 510(k) application to the FDA.• Engage in various phases of verification and validation, as well as design review meetings.• Develop testing protocols for verification of design engineering requirements.• Manufacturing, and quality control of over 300 product builds.• Ensure readiness for new components and/or assemblies and protocols.• Contribute new techniques to solve technical processes and improve existing testing procedures.
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UTSA College of Engineering
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United States
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Higher Education
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1 - 100 Employee
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Student Research Assistant
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Jun 2018 - May 2019
Worked alongside graduate students as well as post doctorates in a tissue engineering laboratory under Eric Brey, Ph. D. Our project consisted in analyzing and quantifying some scanning electron microscope images using ImageJ and Fiji softwares. Adipocytes are endocrine organs with diverse metabolic roles in regulating whole-body physiology and is a storage depot for energy. Laminin alpha 4 (LAMA4) is a protein that is located in the basement membrane in the extracellular matrix that plays an important role in fat accumulation. Recent discoveries have shown that LAMA4 null mice (KO) exhibit significantly higher energy expenditure as well as resistance to age and diet-induced obesity when compared to wild type mice (WT). The purpose of this research was to examine ECM structure from LAMA4 KO and WT mice. We found that the ECM density and fiber size was altered in matrix produced by laminin alpha 4 free cells relative to wild type cells. While diameter dimensions in both were relatively the same. The presence of ‘‘clumps’’ or fiber aggregates was also evident in the SEM images. This work provided critical information in understanding cell-ECM interactions in adipose tissue.
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Education
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The University of Texas at San Antonio
Bachelor of Science - BS, Biomedical/Medical Engineering -
The University of Texas Rio Grande Valley
Pre-Engineering