Freelancer profile translated to English.
Back to original languageAbout Meriam
I hold a PhD in Biology, Chemistry, and Health.
I have extensive experience in:
- Assisting luxury cosmetic brands with their regulatory processes, overseeing projects from formulation to market launch, leveraging my network of partners (experienced formulators, partner laboratories, toxicologists with over 20 years of experience, etc.).
I have also spent years supporting cosmetic product manufacturers in their regulatory endeavors to prepare their CE marking dossiers in compliance with current regulations.
I have been responsible for drafting, preparing, or updating various CE marking dossiers for medical devices of all classes: IIa, IIb, I, and III.
With:
- Drafting/updating (MDD/MDR transition) technical file documents (classification, GSPR, list of applicable standards, etc.)
Drafting risk management files, usability engineering reports, packaging and labeling, as well as post-market clinical follow-up plans and reports.
Technical and Medical Fields:
-- Medical devices (nasal spray, throat spray, syrup) for the treatment or prevention of ENT diseases or respiratory infections in children and adults
— Perineal rehabilitation devices
— Surgical masks
— Endodontic devices
In addition to this, I have multiple experiences in preparing substance reports to justify the non-application of medical device classification as drugs: borderline products.
French
Native or bilingual
English
Native or bilingual
Arabic
Native or bilingual
Can work on-site
Toulouse (up to 50km)
Experience
- ASPE CONSEILCONSULTANT IN REGULATORY AFFAIRS AND QUALITYCONSULTING AND AUDITSFebruary 2022 - March 2025 (3 years and 1 month)Writing regulatory report according to the requirements Regulation and applicable standard, management risks files, biological assessment reports, and engineering reports, IFU and labeling, files, substances report (for borderline products). The implementation of the QUALIOPI quality system+ QUALIOPI certification from AFNOR, skills=[]
- TOXIPLAN,SCIENTIFIC EXPERT AND CLIENT MANAGERJanuary 2019 - January 2020 (1 year)Toulouse, FranceAssisting cosmetic brands in their regulatory processes + business development, skills=[SkillTranslatableContent(id=Formulation cosmétique, type=GLOBAL, name=Cosmetic Formulation), SkillTranslatableContent(id=Dispositifs médicaux, type=GLOBAL, name=Medical Devices)]
- INVIPLAT.FounderCONSULTING AND AUDITSJanuary 2026 - Today (5 months)Toulouse, FrancePlatform offering regulatory and scientific support services for pharmaceutical industries, cosmetic brands, and medical device manufacturers., skills=[SkillTranslatableContent(id=MDR 2017/745, type=GLOBAL, name=MDR 2017/745), SkillTranslatableContent(id=Regulatory Compliance, type=GLOBAL, name=Regulatory Compliance), SkillTranslatableContent(id=Formulation cosmétique, type=GLOBAL, name=Cosmetic Formulation), SkillTranslatableContent(id=ISO 10993, type=GLOBAL, name=ISO 10993), SkillTranslatableContent(id=Medical Devices, type=GLOBAL, name=Medical Devices)]
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Education
- Doctorate in Biology Chemistry and HealthFaculty of Pharmacy of Toulouse2016Doctorate in Biology Chemistry and Health
- Engineering in biological engineeringINSA Toulouse2011Engineering in biological engineering