OUMAIMA DARKAOUI
Quality And Regulatory Affairs Manager
FRANCE
Summary
Dynamic recent graduate with an academic background and transferable skills gained through solid professional experiences, seeking an opportunity starting in August.
Overview
8
8
years of professional experience
5
5
Languages
Work History
Regulatory Affairs Specialist
Johnson & Johnson Medtech
06.2024 - Current
- Prepared and submitted regulatory file applications and supporting documentation.
- Worked with governance committees to make and evaluate plans.
- Implemented regulatory guidance procedures for [Area of expertise].
Quality and Regulatory Affairs Manager
ISOMED
03.2022 - 05.2024
- Lead the QMS and contribute to enhancing its effectiveness: Assist management in the development of the Quality Policy, quality objectives, action plans, and monitoring the performance of the Integrated Management System.
- Plan and monitor the conduct of audits (internal, certification/follow-up) and coordinate the implementation of improvement actions.
- Supervise the processing of registration files for medical devices in accordance with applicable regulatory requirements.
- Develop the training plan, defining educational content.
Intern
GYNEBIO PHARMA
11.2021 - 02.2022
- Participate in the creation and implementation of processes, procedures, and forms.
- Conduct the annual product review and interpret results based on the graphs produced in Minitab for effective decision-making, as well as draft the report and the corresponding procedure.
Internship in Quality for Final Year Project
Meatcorp
02.2021 - 08.2021
- Quality control of raw materials: Verification of the freshness, origin, and compliance of fish and other ingredients before their processing.
- Management of complaints and non-conformities: Analysis of customer feedback and implementation of corrective and preventive actions.
Internship in Quality for Final Year Project
Dindy
02.2019 - 06.2019
- Development of the HACCP plan: Define Critical Control Points (CCPs) and establish preventive measures to ensure product safety.
- Internal audit: Participate in audits to assess the compliance of practices with the requirements of the ISO 22000 standard.
Introductory Internship
canpack Morocco
06.2017 - 07.2017
- Review of the entire production chain
- Carry out chemical analysis to ensure the quality of aluminum cans
Education
Master 2 - Quality Engineering of Bioproducts
University of Rouen, IUT of Evreux
09.2024 - Juin 2025
Specialized Master's - Quality Control And Management
Faculty of Sciences Ben M'sik
09.2019 - Juin 2021
Professional Bachelor's Degree - Enhancement of Local Products, Chemistry Option
Faculty of Sciences Mohammed V
09.2018 - Juin 2019
University Diploma of Technology - Process Engineering
Higher School of Technology FES
09.2016 - Juin 2018
High School Diploma - Experimental Sciences
School Group Manahij El Irfane
09.2015 - Juin 2016
Skills
- Adherence to quality standards
- Medical device regulations expertise
- Quality assurance methodologies
- Critical thinking techniques
- Minitab proficiency
- Cross-functional teamwork
- Project Management
- Flexibility in dynamic environments
- Responsive to new challenges
Personal Information
Timeline
Master 2 - Quality Engineering of Bioproducts
University of Rouen, IUT of Evreux
09.2024 - Juin 2025
Regulatory Affairs Specialist
Johnson & Johnson Medtech
06.2024 - Current
Quality and Regulatory Affairs Manager
ISOMED
03.2022 - 05.2024
Intern
GYNEBIO PHARMA
11.2021 - 02.2022
Internship in Quality for Final Year Project
Meatcorp
02.2021 - 08.2021
Specialized Master's - Quality Control And Management
Faculty of Sciences Ben M'sik
09.2019 - Juin 2021
Internship in Quality for Final Year Project
Dindy
02.2019 - 06.2019
Professional Bachelor's Degree - Enhancement of Local Products, Chemistry Option
Faculty of Sciences Mohammed V
09.2018 - Juin 2019
Introductory Internship
canpack Morocco
06.2017 - 07.2017
University Diploma of Technology - Process Engineering
Higher School of Technology FES
09.2016 - Juin 2018
High School Diploma - Experimental Sciences
School Group Manahij El Irfane
09.2015 - Juin 2016
Similar Profiles
SWANUBHAV RATHSWANUBHAV RATH
Product Owner- Web and Digital Platforms at Johnson and Johnson MedTechProduct Owner- Web and Digital Platforms at Johnson and Johnson MedTech
Daniel HillDaniel Hill
Manager, Sports Capital Sales - East at Johnson & Johnson MedTechManager, Sports Capital Sales - East at Johnson & Johnson MedTech
Quintin AshiteiQuintin Ashitei
Surgical Sales Consultant at Johnson & Johnson MedTech OrthopedicsSurgical Sales Consultant at Johnson & Johnson MedTech Orthopedics
Chaima JGUIRIMChaima JGUIRIM
Chef de projet at Abeille AssurancesChef de projet at Abeille Assurances
Fabien DENISFabien DENIS
Conducteur de ligne atelier plantes at Les 2 Marmottes (SCC Diethamix)Conducteur de ligne atelier plantes at Les 2 Marmottes (SCC Diethamix)