I have over 10 years of experience in Clinical Evaluation, Clinical Investigation, Regulatory Affairs, Quality Assurance and Medical Device Design.
My career began in 2003, when I went to study Biological Sciences in Ouro Preto (UFOP). I then completed a master's degree in Cellular Biology (UFMG).
After working as a consultant for GE Healthcare Lifesciences, I decided to pursue a doctorate in Protozoan Immunobiology (UFOP).
Since then, I have worked in companies that manufacture various types of medical devices, such as biological heart valves, cardioverters, intraocular lenses, intrastromal corneal rings, among others.
In my career, I have implemented the Clinical Research sector, monitored numerous clinical studies, revitalized the Quality Management System, prepared over 100 clinical evaluation reports and other documents that make up the Technical Documentation, such as: PMCF, risk management, biological evaluation, usability, instructions for use.
I played a significant role in the process of obtaining the CE Mark and am responsible for the certification project in accordance with Regulation (EU) MDR 2017/745.
I am an ISO 13485:2016 Lead Auditor and have performed audits at national and international companies.
I believe that my clinical and regulatory knowledge combined with my academic knowledge favor my activities, whether related to literature searches, critical analysis of articles and scientific writing on the safety and performance of medical devices, as well as those related to good manufacturing practices, root cause identification and definition of action plans.
I manage a team of 12 employees with different backgrounds: engineers, chemists, biomedical scientists, pharmacists and physicists. Some of these have master's degrees and others have PhDs.
I provide theoretical training for surgeons and partners, guide doctors on the correct handling of products and supervise medical device implant surgeries.More...
James Pepper
Digital Transformation Consultant@Virar Digital
Verified
James Pepper is a renowned Digital Transformation Consultant.
With over a decade of experience in digital strategy and transformation, James has a seasoned understanding of how to navigate the ever-evolving digital landscape.
His expertise lies in helping organizations build, implement, and optimize digital solutions to improve operational efficiency and drive business growth.
Prior to joining Virar, James held various consulting and leadership roles in prominent tech firms.
He holds a Master’s degree in Information Technology Management. Known for his forward-thinking approach, James continues to guide businesses in leveraging the latest digital trends and technologies to stay competitive.More...