プロフィール詳細

プロジェクトを作成

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Ashley K.に依頼

United States

Medical Device Regulatory Affairs & QA Specialist | EU IVDR, ISO 13485, CAPA, Post-Market Surveillance

プロフィール概要

Regulatory Affairs and Quality Assurance specialist with nearly three years of hands-on experience supporting medical device and IVD manufacturers through the full product lifecycle. I author EU IVDR Technical Files across Class A, B, and C devices, manage CAPA processes and internal audits to ISO 13485, and lead post-market surveillance and Health Canada reporting. I've supported external audits with notified bodies including BSI, and I work regularly on export compliance and regulatory labeling transitions (e.g., EC REP/EU REP, ISO 15223 symbol updates). I help clients with technical file authorship and gap assessments, CAPA investigation and response writing, internal audit preparation and findings remediation, post-market surveillance reporting, and regulatory strategy for EU and Health Canada submissions. I'm comfortable working independently on tight deadlines and translating complex regulatory requirements into clear, audit-ready documentation. Currently pursuing RAC certification through RAPS.

専門分野

• ★ ISO 13485
• ★ ISO 14971
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Gray Literature Search
• ☆ Skills Training
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Data-Driven Decision Making
• ☆ International Law
• ☆ Project Management
• ☆ Risk Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing

Research Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

Consulting Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Global Regulatory Affairs Specialist

Helena Laboratories, Corp.

5月 2023 - 現在

学歴

Bachelor of Science in Biology

Lamar University

8月 2018 - 12月 2022

認定資格

• Medical Device Establishment Licensing and Post-market Regulation

  Health Canada

  6月 2024 - 現在

• Quality Processes in Greenlight Guru - Certificate No: h4ebt6bq5tcv

  Greenlight Guru

  9月 2023 - 現在

• Audit Management in Greenlight Guru - Certificate No: f34piedae3pm

  Greenlight Guru

  9月 2023 - 現在

• CAPA Management in Greenlight Guru - Certificate No: e9qxne5b2tac

  Greenlight Guru

  8月 2023 - 現在

• An Overview of Document Management - Certificate No: kaaunqnq48j7

  Greenlight Guru

  8月 2023 - 現在

• Nonconformance Management in Greenlight Guru - Certificate No: 3ppfntfee9ob

  Greenlight Guru

  8月 2023 - 現在

• Understanding How Medical Devices are Regulated in Canada

  Health Canada

  6月 2023 - 現在

• Quality Processes in Greenlight Guru - Certificate No: h4ebt6bq5tcv

  Greenlight Guru

  1月 2023 - 現在