Profile Details

Create Project

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USD 280 /hr

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Hire Dr. Seval K.

Turkey

USD 280 /hr

Global Life Science Advisor – Quality Assurance & Controls - Regulatory Affairs - R&D - Production - Clinical Affairs

Profile Summary

Quality Assurance , Validation Planning and Reporting , Medical Device Clinical Study Design and Reporting by CER PSUR and else. , FDA Registeration and US Agent Services , Regulatory Compliance and New Product Research and Development through its clinical data and Process Improvent of the Production Lines and Efficiency-Focused Cost-Reduction Engineering

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Regulatory Affairs

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing

Research Gap Analysis, Scientific and Technical Research

Consulting Legal Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

Work Experience

Consultant

Services of Engineering Validation & Consultancy

June 2023 - Present

Education

Chemistry PhD

Bolu Abant Izzet Baysal University

February 2020 - January 2026

Certifications

• Fall School on Programmable Photonic Quantum Computers

  TUBITAK RESEARCH INSTITUTE FOR FUNDAMENTAL SCIENCES

  September 2025 - Present

• ISO 13485 Internal Assessor

  Inovation Consultancy

  January 2025 - Present

• IATF 16949 Automotive Quality Management System (APQP-PPAР-FMEA-SPC-MSA)

  Istanbul Quality Academy

  November 2024 - Present

• Effectively Managing Clinical Data Collection Using cost-Sensitive Methods and PMCF

  Qserve Clinical B.V

  September 2024 - Present

• New Period Medical Device Market Launch Processes

  EUMed

  May 2023 - Present

• Clinical evaluation under MDR with case studies from the notified body GMED

  Eclevar

  May 2023 - Present

• HPLC-GC

  Perkin Elmer

  April 2023 - Present

• FDA Regiateration

  IKMIB by Tania A. Martinez FDA Member

  October 2022 - Present

• UKCA Marking (Certification) for Medical Devices

  Tumdef

  September 2022 - Present

• MDR

  NB - Szutest

  May 2022 - Present

• Responsible Manager

  TITCK

  April 2022 - Present

• Sales and Promotion Responsible

  TITCK

  April 2022 - Present

• Clinical Studies Responsible

  TITCK

  April 2022 - Present

• Clinical Studies for Medical Devices

  TITCK

  April 2022 - Present

• MDR : Medical Device Technical Documentation Preparation Training

  EUMed

  March 2022 - Present

• Minitab and Statistics

  Sigma Center Kalite ve Verimlilik Danışmanlığı

  December 2021 - Present

• Plastics Production

  Metin Bilgili Consultancy

  December 2021 - Present

• ISO 27001 Information Assurance Standards

  Bimed

  December 2021 - Present

• Production Process Validation

  AdviQual

  October 2021 - Present

• Microbiological Environment Control

  Bıçakcılar Medical Devices

  October 2021 - Present

• Controlling of Designing Steps

  AdviQual

  October 2021 - Present

• SAP Success Factors & SAP Success Factors Personnel Affairs Module

  Bimed

  August 2021 - Present

• Corporate Awareness and Effective Communication

  Bimed

  May 2021 - Present

• Packaging Validation ISO 11607-1, ISO 11607-2, ISO 868-5

  AdviQual

  May 2021 - Present

• ISO 13485: Quality Management for Medical Devices

  Kiwa

  March 2021 - Present

• Workdays and Periodic Health Education

  Bimed

  March 2021 - Present

• Usability

  Adviqual - Tümdef

  January 2021 - Present

• Cleaning Validation

  Ecolab

  January 2018 - Present

• Pharmaceutical Production, Microbiology, QA, QC, Hygyene,Calibration,Validation,Water Puriffication HVAC, GxP, Health and Safety etc...

  İdol Pharmaceutical

  May 2017 - Present

• Chemistry Teaching

  Iskur On-the-Job Training Program

  August 2016 - Present

• 5th National Inorganic Chemistry Congress

  Mersin Univercity

  April 2015 - Present

• Nanotechnology: Research and Development

  Lithuanian Academy of Sciences

  January 2014 - Present

• Diction Training

  Elginkan Foundation

  October 2013 - Present

• Speed Reading and Memory Techniques

  Elginkan Foundation

  September 2013 - Present

• Effective Communication

  CPA Consultancy

  February 2013 - Present

• ISO 9001 Internal Assessor

  CPA Consultancy

  February 2013 - Present

• Paint Production Management

  Chemists Association

  January 2011 - Present

• How to Make Money from Foreign Trade

  İzgören - Akin

  October 2007 - Present