Profile Details

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USD 150 /hr

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Hire Dr. Imen F.

France

USD 150 /hr

Freelance: Quality Assurance/ Regulatory Affairs specialist in Medical Devices (MD)

Profile Summary

PHD pharmacist, with more than 5 years of experience in Quality Assurance (QA) and Regulatory Affairs (RA). My experience enables me to help you on: -The compliance of your Quality Management System (QMS) (ISO 13485/ISO14971/EU regulatory (2017/745; 2017/746) -The implementation/support of the Post Market Surveillance (PMS) system -Editing MD procedures/SOP -Ensuring MD vigilance trainings/ activity implementation -Ensuring regulatory monitoring (literature research and analysis) -The regulatory compliance of Drug/MD advertising material

Subject Matter Expertise

• ☆ Pharmacy
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Literature Search

Services

• Writing
• Research
• Consulting

Writing Technical Writing, Copywriting

Research Gap Analysis, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Work Experience

Quality project support

Real staffing/Bio Rad Laboratories Inc

June 2022 - Present

Medical device, Medical device vigilance, Quality Expert. Pharm. D.

Guerbet

November 2020 - May 2022

Quality expert

EAPI

February 2020 - October 2020

Pharmacovigilance expert

Pharmacovigilance National Center

January 2019 - January 2020

Biochemistry internship/Intensive Cardiologic care unit

La Rabta University Hospital

January 2018 - December 2018

Education

Quality Expert

EAPI

February 2020 - October 2020

Masters (Science)

European MSc in Pharmacovigilance University of Bordeaux, France

September 2016 - June 2018

PHD

Faculty of Pharmacy, Monastir, Tunisia

January 2010 - January 2017

Certifications

• Speak English Professionally: In Person, Online & On the Phone

  Georgia Institute of technology

  May 2022 - Present

• EU Medical Device Regulatory Affairs

  udemy

  April 2021 - Present

• Six Sigma principles

  University system of Georgia

  https://coursera.org/share/15b74421afdefdca814c6822451f2eb0

  April 2021 - Present

• Medical devices , the basics of quality

  Internal training

  February 2021 - Present

• Rules for the development and registration of medical devices

  Internal training

  January 2021 - Present

• Impact of the new regulation on medical devices

  Internal training

  January 2021 - Present

• Quality Management System (QMS) - Documentary System

  udemy

  March 2020 - Present

• From smallpox vaccine to future technologies,

  University of KU Leuven, Belgium

  January 2020 - Present

• Good Manufacturing Practices (GMP) and good distribution Practices (GDP)

  Internal training

  January 2019 - Present