Profile Details

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Hire Dr. Sharma P.

United Kingdom

USD 40 /hr

Highly skilled QA and RA certified lead auditor with diverse industry experience in more than 56 markets with UK's NB

Profile Summary

Implementing ISO13485 and ISO9001 quality systems for various market requirements building compliant and conformant QMS and product regulatory technical documentations across MDSAP, EFTA, ASEAN and other major markets on active, non-active devices, implants, SaMD including combination products (CDx and LDT)

Subject Matter Expertise

• ☆ Biostatistics
• ☆ Molecular Biology
• ☆ Genetics
• ☆ Biotechnology & Bioengineering
• ☆ Biomedical Engineering
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ Project Management
• ☆ Risk Management
• ☆ Six Sigma
• ☆ Management Consulting

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, General Proofreading & Editing

Work Experience

Pricipal Consultant

Elixir Medicals Ltd

July 2016 - Present

Education

PhD - Biomedical Sciences (microfluidics on platelet function testing on CVD)

University of Reading

September 2023 - Present

M.Sc. (by Research) Biomedical Sciences

University of East London

January 2007 - July 2009

M.Sc. Genetics with Toxicology

Osmania University

June 2000 - April 2002

BSc - Microbiology, Genetics and Chemistry

Osmania University

June 1997 - April 2000

Certifications

• Introduction to EU IVDR 2017/746 (Cert. No. 44192877 / 146893652)

  SGS

  March 2020 - Present

• Introduction to EU MDR 2017/745 (Cert. No. 44192895 / 146893653)

  SGS

  February 2020 - Present

• QMS Auditor Refresher Based on ISO13485:2016 (Cert. No. ENR-00497208)

  British Standards Institute

  https://members.quality.org/quality/atp_Profile.aspx?ID=01180271

  July 2018 - Present

• QMS Lead Auditor Based on ISO13485:2003 (Cert. No. A1918)

  Kelmac Group (Course No. A17584)

  https://members.quality.org/quality/atp_Profile.aspx?ID=01180203

  January 2015 - Present

Publications

DISSERTATION THESIS

@misc{Pokkuluri_2006, doi = {10.2210/pdb2ir7/pdb}, url = {https://doi.org/10.2210%2Fpdb2ir7%2Fpdb}, year = 2006, month = {oct}, publisher = {Worldwide Protein Data Bank}, author = {S. Pokkuluri and S. V. Pokkuluri and C. H. Chilakalapudi}, title = {{COMPARATIVE} {MODEL} {OF} {PANTOTHENATE} {SYNTHETASE} {FROM} {AQUIFEX} {EOLICUS} {STRAIN} {VF}5}} .

@misc{Pokkuluri_2006, doi = {10.2210/pdb2ioz/pdb}, url = {https://doi.org/10.2210%2Fpdb2ioz%2Fpdb}, year = 2006, month = {oct}, publisher = {Worldwide Protein Data Bank}, author = {S. VISWESWARA Pokkuluri and SUNITHA Pokkuluri and S. KUMARI Nunna}, title = {{THEORETICAL} {STRUCTURE} {PREDICTION} {OF} N5N10-{METHENYLTETRAHYDROMETHANOPTERIN} {CYCLOHYDROLASE} {FROM} {ARCHEAN} {METHANOBACTERIUM} {THERMOAUTOTROPHICUM} {DETLA} {\textquotesingle}H{\textquotesingle} {STRAIN}}} .