Profile Details

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USD 200 /hr

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Hire Marysa M.

United States

USD 200 /hr

Medical Devices - EU MDR SME - Clinical Eval and PMCF

Profile Summary

Marysa is a Medical Device Regulatory Consultant with over six years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, medical device development, device regulations/standards, and clinical evaluation/PMCF strategies. Marysa has expertise in the overall project management and the writing of clinical evaluation documents, Clinical Literature Reviews, and PMS/PMCF Documents.

Subject Matter Expertise

• ★ Medical Device Regulatory Consulting
• ★ European Medical Device Regulation (MDR)
• ★ Clinical Evaluation Reports (CER)
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Technical & Scientific Writing

Services

• Writing
• Consulting

Writing Clinical Trial Documentation, Technical Writing

Consulting Scientific and Technical Consulting

Work Experience

Senior Manager, Consulting

Global Regulatory Writing and Consulting

March 2020 - Present

EU MDR CER Writer

Smith & Nephew

September 2018 - March 2020

Senior Clinical Affairs Specialist

NxStage Medical

December 2017 - September 2018

Clinical Research Associate

ConforMIS

December 2016 - December 2017

Research Assistant

University of Massachusetts

January 2012 - May 2014

Education

MSc. Regulatory Affairs

Northeastern University

January 2016 - June 2017

BSc. in Psychology

University of Massachusetts Amherst

September 2010 - May 2014

Certifications

• Certification details not provided.