Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 120 /hr

★★★★★

☆☆☆☆☆

Hire Violet S.

United States

USD 120 /hr

EU MDR Clinical Evaluation Consultant | CER, SSCP, PMCF | Author of Peer-Reviewed Publications | RAC Certified | 10+ yea

Profile Summary

I am an EU MDR clinical evaluation specialist and RAC-Devices certified medical writer with over four years of experience developing Clinical Evaluation Reports (CERs) for medical device manufacturers across multiple therapeutic areas, including cardiac rhythm management. I have supported notified body submissions, gap assessments, literature reviews, PMCF documentation, SSCPs, CEPs, and Canada Summary Reports. In addition to regulatory clinical evaluation writing, I author scientific publications, conference abstracts, and technical posters, translating complex clinical and scientific data into clear, submission-ready documentation for both regulatory and scientific audiences. I focus on producing regulator-ready CERs grounded in strong clinical evidence, clear benefit-risk analysis, and alignment with MEDDEV 2.7/1 Rev. 4 and EU MDR expectations. Known for quickly synthesizing complex clinical data into high-quality deliverables, I collaborate effectively with regulatory, clinical, and cross-functional teams to meet tight timelines. Available for contract CER development, remediation, scientific writing, and MDR clinical evaluation strategy support.

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ★ Clinical Evaluation Reports (CER)
• ★ Scientific Proofreading & Editing
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications

Services

• Writing

Writing Medical Writing, Technical Writing

Work Experience

Lead Medical Writer

Global Regulatory Writing & Consulting

December 2021 - February 2026

Graduate Student Researcher

University of Michigan - Ann Arbor

September 2017 - September 2021

Education

Masters in Macromolecular Science & Engineering

University of Michigan - Ann Arbor

September 2017 - September 2021

Bachelor of Chemical Engineering

University of New Mexico - Albuquerque

August 2013 - May 2017

Certifications

• Regulatory Affairs Certification (RAC- Devices)

  Regulatory Affairs Professional Society (RAPS)

  https://bcert.me/sncmistel

  January 2025 - December 2026

Publications

JOURNAL ARTICLE

Violet V. Sheffey, Emily B. Siew, Eden E. L. Tanner, Omolola Eniola‐Adefeso (2022). PLGA's Plight and the Role of Stealth Surface Modification Strategies in Its Use for Intravenous Particulate Drug Delivery . Advanced Healthcare Materials.

P. Takunda Chazovachii, Julie M. Rieland, Violet V. Sheffey, Timothy M. E. Jugovic, Paul M. Zimmerman, Omolola Eniola-Adefeso, Brian J. Love, Anne J. McNeil(2021). Using Adhesives to Capture Microplastics from Water . ACS ES&T Engineering. 1. (12). p. 1698--1704. American Chemical Society ({ACS})