プロフィール詳細

プロジェクトを作成

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Silvija B.に依頼

Croatia

Regulatory & Technical Documentation Specialist | ISO 17025/Medical Devices | 20 yrs in Healthcare & Optical Radiation

プロフィール概要

I am a regulatory and technical documentation specialist with 20 years of experience working in a highly regulated ISO 17025 laboratory serving hospitals, clinics, and medical-device clients. My background includes optical radiation measurement (UV/IR/laser), risk evaluation, conformity assessment, and writing audit-ready documentation for healthcare and medical-technology users. I have extensive experience developing and maintaining QMS documentation, SOPs, work instructions, technical reports, validation records, and regulatory-style summaries used by clinicians, auditors, and national health authorities. I am skilled in translating complex technical and regulatory requirements into clear, structured, and compliant documents suitable for audits and inspections. I support clients who need high-quality, accurate documentation for medical devices, clinical environments, laboratory operations, and regulatory submissions.

専門分野

• ★ Medical Device Validation
• ★ ISO 13485
• ★ SOP & Protocol Writing
• ☆ Applied Physics
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 14971
• ☆ Healthcare Administration & Management
• ☆ Healthcare Quality Improvement
• ☆ Occupational Health & Safety
• ☆ Workplace Safety Assessment
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Feasibility Studies
• ☆ Gap Analysis
• ☆ Regulatory Writing
• ☆ Nonclinical Study Documentation
• ☆ Medical Writing
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ Instructional Materials
• ☆ Experimental Protocols
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Case Studies

サービス

• Writing
• Research
• Consulting

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Feasibility Study, Gap Analysis, Scientific and Technical Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

職務経験

Regulatory & Technical Documentation Specialist

Independent Consultant

9月 2025 - 現在

Deputy Head of Laboratory & Quality Manager

METRON INSTRUMENTS d.o.o.

9月 2005 - 4月 2025

Teaching Assistant (Physics I)

UNIVERSITY OF ZAGREB, FACULTY OF CHEMICAL ENGINEERING AND TECHNOLOGY

10月 2004 - 2月 2005

学歴

MSc in Physics

UNIVERSITY OF ZAGREB, FACULTY OF SCIENCE, DEPARTMENT OF PHYSICS

10月 1996 - 5月 2004

認定資格

• Transition to ISO/IEC 17025 2017 Practical Implementation

  CROLAB

  https://www.crolab.hr/

  1月 2019 - 現在

• Risk Management in Laboratories, Certification and Inspection Bodies

  CROLAB

  https://www.crolab.hr/

  1月 2014 - 現在

• ISO 17025 Internal Auditor

  HMD

  https://hmd.hr/

  1月 2009 - 現在