Profile Details

Contact

★★★★★

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USD 50 /hr

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☆☆☆☆☆

Hire Nida A.

Pakistan

USD 50 /hr

Experienced MDD and MDR certified CER/Technical File Writer with 5+ years of experience with multinational industries

Profile Summary

An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR, ISO-10993, and FDA compliance. Provided strategic support in regulatory affairs, post-market product surveillance, and quality assurance in CE marking of EU Class I, IIa, IIb or III medical devices by writing Clinical Evaluation Reports (CERs) providing clinical evidence of the device's state of the art for medical treatment and its safety and performance and response to notified body feedback. I would be eager to consult on new projects moving forward.

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ★ Regulatory Writing
• ★ Clinical Evaluation Reports (CER)
• ☆ Post-Market Surveillance
• ☆ ISO 13485
• ☆ Regulatory Affairs
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Technical & Scientific Writing

Services

• Writing
• Research

Writing Technical Writing

Research Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review

Work Experience

Director Technical Evaluation

Kounter Intuitive technology

June 2014 - Present

Director (Technical Evaluation)

Kounter Intuitive Technologies

March 2014 - Present

Education

BSC Biomedical Engineering

Riphah International Univeristy

May 2009 - May 2012

Law (LLB Honours)

London School of Economics and Political Science, University of London

January 2007 - January 2009

A-levels

Roots College International

May 2004 - May 2006

Certifications

• ISO 14971:2019

  SGS

  December 2022 - Present

• ISO 13485 lead auditor

  SGS

  March 2020 - Present

• ISO 9001: Lead Auditor

  SGS

  January 2019 - Present

• MDR lead Auditor

  SHS

  May 2017 - Present