Ester Carrasco Email & Phone Number
Who is Ester Carrasco? Overview
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Ester Carrasco is listed as Head of Client Services at Springborne Life Sciences, based in Toronto, Ontario, Canada. AeroLeads shows a matched LinkedIn profile for Ester Carrasco.
Ester Carrasco previously worked as Regulatory & Quality Compliance Consultant at Erc Consulting- Medical Device Consultant and Regulatory Affairs Medical Device Intern at Pharmalex. Ester Carrasco holds Master Of Engineering - Meng, Bioengineering And Biomedical Engineering from University Of Toronto.
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About Ester Carrasco
Medical device regulatory compliance strategist, providing support to medical device startup businesses and established companies for regulatory and quality strategies for rapid commercialization of innovative medical devices. Support clients with agile quality management systems implementation, with a special focus on start-up companies that require significant support and training. Experience with many key aspects of quality management, including document and design controls, design transfer, supplier controls, management reviews, and internal audits. Experienced regulatory researcher supporting regulatory strategy for platform technologies and preparing regulatory submissions, including FDA 510(k) Submissions, Pre-submissions (Q-Subs), De Novo, and Breakthrough Device Designation Requests. Enjoy working with dynamic teams whose values inspire constant innovation and drive to provide effective and high quality solutions that improve people’s quality of life.
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Ester Carrasco work experience
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Regulatory & Quality Compliance Consultant
Involved in projects for Springborne Life Sciences and Jin ConsultingProvide support for regulatory submissions, development of agile quality management and consultations on FDA,Health Canada, and MDSAP medical device regulations.
Regulatory Affairs Medical Device Intern
Graduate Student, Medical Device Development Project For Insulin Pump
- Collaborated closely with a team of 4 graduate students to develop optimized insulin pump design that mitigates human factor error and creates a more user-friendly device.
- Applied ISO and IEC standards including ISO 13485, ISO 14971 and IEC 62304 to meet regulatory requirements and medical device standards through concept and planning phase of design control.
- Responsible for organizing and conducting professional interviews with diabetes users, research directors, and human factors specialists.
Business Support
- Managed payroll for employees and verified data was collected from the responsible foreman on-site
- Effectively handled and delivered biweekly Ceridian payroll reports to the accounting department
- Communicated positively with employees with questions regarding payroll related issues
- Successfully implemented a new format to record the employee hours
- Maintained the employee hour records updated on the database
Mobile Phone Based Ecl Instrumentation
- Developed a compact, affordable and user-friendly alternative to electrochemiluminescence (ECL) instrumentation that allows users to capture and analyze various concentrations of solution
- Tested multiple solution concentrations to determine the optimal range that can be analyzed by the device
- Utilized Solidworks to design optimal 3D model for 3D printing
- Documented specifications and operational procedures by developing a user manual
- Implemented the device as a learning tool in chemistry course on campus for feedback and performance evaluation from students and professors.
Research Assistant- Department Of Engineering And Computer Science
- Collected, captured and analyzed data for Electrochemiluminescence (ECL)-Biosensor to determine best suitable solution concentration.
- Investigated methods to develop a compatible, affordable and user-friendly device that would permit the biosensor to be available to a larger range of users
- Electrochemiluminescence (ECL) immunoassay research
- Collaborated and examined data with other students effectively and reported progress to the advisor for review
Ester Carrasco education
Master Of Engineering - Meng, Bioengineering And Biomedical Engineering
Bachelor Of Engineering (B.Eng.) Cum Laude, Bachelor Of Science In Engineering W/ Emphasis In Chemical, Spanish Studies Minor
Frequently asked questions about Ester Carrasco
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What company does Ester Carrasco work for?
Ester Carrasco works for Springborne Life Sciences.
What is Ester Carrasco's role at Springborne Life Sciences?
Ester Carrasco is listed as Head of Client Services at Springborne Life Sciences.
Where is Ester Carrasco based?
Ester Carrasco is based in Toronto, Ontario, Canada while working with Springborne Life Sciences.
What companies has Ester Carrasco worked for?
Ester Carrasco has worked for Springborne Life Sciences, Erc Consulting- Medical Device Consultant, Pharmalex, University Of Toronto, and E.D.S Contracting And Repair Services Ltd..
How can I contact Ester Carrasco?
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What schools did Ester Carrasco attend?
Ester Carrasco holds Master Of Engineering - Meng, Bioengineering And Biomedical Engineering from University Of Toronto.
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