プロフィール詳細

プロジェクトを作成

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Violet S.に依頼

United States

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

プロフィール概要

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.

専門分野

• ★ 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

サービス

• Writing

Writing Medical Writing, Technical Writing

職務経験

Lead Medical Writer

Global Regulatory Writing & Consulting

12月 2021 - 2月 2026

Graduate Student Researcher

University of Michigan - Ann Arbor

9月 2017 - 9月 2021

学歴

Masters in Macromolecular Science & Engineering

University of Michigan - Ann Arbor

9月 2017 - 9月 2021

Bachelor of Chemical Engineering

University of New Mexico - Albuquerque

8月 2013 - 5月 2017

認定資格

• Regulatory Affairs Certification (RAC- Devices)

  Regulatory Affairs Professional Society (RAPS)

  https://bcert.me/sncmistel

  1月 2025 - 12月 2026

出版物

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). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1698--1704. American Chemical Society ({ACS})