Freelancer profile translated to English.

Description

With a strong background as a QARA (Quality, Regulatory Affairs) specialist in the Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDMD) sector, I ensure the compliance of health products with international standards and current regulations. My expertise encompasses the implementation of quality management systems and navigating the complex landscape of regulatory requirements.

My mission is to contribute to bringing safe and effective medical devices to market, ensuring their quality and compliance throughout their lifecycle.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
Arabic
Native or bilingual

Workplace preferences

Can work on-site

Paris (up to 50km)

Idsolution
Technical Writer MD
MEDICAL
December 2023 - Today (2 years and 6 months)
Montpellier, France
Define the scope of the activity (Instructions for Use (IFU) to be updated or added).
Identify stakeholders.
Plan IFU writing, agree on deadlines with stakeholders.
Monitor actions and ensure their completion.
Validate IFU content with involved stakeholders.
Plan regular reviews based in particular on feedback from risk analyses of Periodic Safety Update Reports (PSURs), as well as on updates to regulatory requirements and new guidelines.
Ensure geographical zone-specific compliance.
Bio-Rad
Post Market Surveillance (PMS) Expert
BIOTECH
June 2022 - November 2023 (1 year and 6 months)
Paris, France
Ensure the implementation of PMS (post-market surveillance) activities within the framework of compliance with European Regulation 2017/746 (IVDR).
Implementation of the "Complaint Review Board" (CRB) to track customer complaint trends on various products and decide with stakeholders on actions to be taken.
Monitor the proper implementation of CAPAs, Field Actions, etc.
Update procedures in accordance with MDR and ISO 13485.
Prepare for Audits (13485/IVDR/MDSAP).
13485/IVDR/MDSAP
Guerbet
Quality Assurance Manager Medical Devices
MEDICAL
November 2020 - May 2022 (1 year and 7 months)
Paris, France
Ensure the compliance of the Quality Management System (QMS) with current regulations and standards.
Monitor the regulatory compliance of medical devices in accordance with the requirements of EU Regulation 2017/745.
Manage and monitor customer complaints related to medical devices.
Draft/regulatory review of quality documents related to medical devices.
Monitor corrective and preventive actions (CAPA) related to customer complaints concerning medical devices.
Participate in the preparation and conduct of audits related to the medical device quality management system (MDSAP, 13485, MDR).
Implement a validation process for medical device vigilance cases between the subsidiary and Guerbet Global.
Regulatory drafting of Periodic Safety Update Reports (PSURs) and post-market surveillance (PMS) systems.
Ensure the regulatory compliance of medical devices and pharmacovigilance/materiovigilance safety cases.
Ensure the review and regulatory validation of promotional and non-promotional materials related to drugs and medical devices.