Profile Details

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Hire Dr. Grace C.

Malaysia

USD 50 /hr

Experienced CER Writer for medical device companies

Profile Summary

1. Clinical Evaluation Report (CER) writer and authoring of Clinical Evaluation Plan (CEP) in accordance with Medical Device Regulation (MDR), 93/42/EEC Medical Device Directive (MDD) and MEDDEV 2.7/1 Rev. 4 for companies such as Bausch and ConvaTec. 2. CEP and CER Technical Reviewer for Johnson and Johnson. 3. Writing PMCF Plans. 4. Performance Evaluation Report (PER) which include authoring of the Performance Evaluation Plan (PEP), Scientific Validity Report (SVR), Analytical Performance Report (APR) and Clinical Performance Report (CPR) in accordance with the In Vitro Diagnostic Device Regulation (IVDR) for companies such as Leica Biosystems Newcastle, Leica Amsterdam and Merck US. 5. Conducting systematic literature searches through databases including EMBASE, Cochrane Library and PubMed.

Subject Matter Expertise

• ★ Medical Devices
• ★ European Medical Device Regulation (MDR)
• ★ Clinical Evaluation Reports (CER)
• ☆ Medical Device Regulatory Consulting
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Work Experience

CER Writer

RQM

February 2020 - Present

Medical Writer

Oro Clean Chemie Sdn Bhd

July 2017 - November 2019

Scientific Officer

Dyamed Biotech Sdn Bhd

April 2016 - April 2017

Education

Doctor of Philosophy (PhD) in Molecular Medicine

University of Malaya

February 2011 - April 2016

Bachelor of Science (Hons) in Biotechnology

UCSI University

May 2006 - July 2009

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

(2015). Antioxidant, antiproliferative, genotoxic and cytoprotective effects of the methanolic extract ofPadina tetrastromaticaon human breast adenocarcinoma and embryonic fibroblast cell lines . Frontiers in Life Science.

In vitro Antimicrobial Activity of Hexane: Petroleum Ether Extracts from Fruits of Momordica charantia L .

Antioxidant and cytotoxic activities of three species of tropical seaweeds .

Effectiveness of Maceration Periods with Different Extraction Solvents on in-vitro Antimicrobial Activity from Fruit of Momordica charantia L .