Profile Details

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Hire JUAN S.

United States

USD 150 /hr

Over 15 years’ experience in directing projects, research and development initiatives, and ensuring compliance in biomed

Profile Summary

• Achieved a 15% reduction in cost annually by recognizing & minimizing risk in the EU MDR project • Controlled accounts & designed budgets for multiples projects of EUMDR of 175 staff. • Deliver subject matter expertise in conducting global product evaluations for disposition, while ensuring compliance to division quality assurance DQA protocol/standards in the USA • Provides work direction, training, and development of team members. May oversee efforts of multiple teams • Monitor’s performance and recommends changes, cost adjustments, or resource additions • Keeps management informed of key issues and changes, which may impact expected business results. May engage and oversee the work of external vendors • Provide technical leadership for the projects. Lead and coordinates activities of engineers and technicians in support of process and equipment development, Lead and participate in documents vs. actual gap analysis activities.

Subject Matter Expertise

• Expertise details not provided.

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, User Research, Feasibility Study, Systematic Literature Review

Consulting Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Concept Development

Work Experience

Global Project Manager

Medtronic

January 2013 - June 2020

Education

Master of Science in Medical Sciences

Quinnipiac University, Hamden, CT

May 2016 - May 2018

Bachelor’s in Biological sciences

College of Mount Saint Vincent College

May 2006 - May 2010

BSc Biology

Universidad Industrial de Santander

May 1987 - May 1993

Certifications

• Detection of Transmissible spongiform encephalopathy agents in Biological products using protein aggregation assays

  FDA

  January 2021 - Present