Dounia
Madame, Monsieur, Actuellement Responsable Recherche et Développement (R&D) et Personne Chargée du Respect de la Réglementation (PRRC), je souhaite donner une nouvelle orientation à ma carrière en mettant mon expertise technique et normative au profit de votre département Affaires Réglementaires. Passionné par la conformité des produits de santé, je suis convaincu que mon double profil constitue un atout majeur pour sécuriser la mise sur le marché de vos dispositifs innovants. Au cours de mon parcours en R&D, j'ai piloté la conception de produits depuis la phase d'idéation jusqu'au marquage CE, en intégrant les contraintes réglementaires dès les premières étapes du cycle de vie (Design Control). En tant que PRRC, j’ai la responsabilité directe de garantir la conformité du dossier technique, de superviser la surveillance après commercialisation (PMS) et d'assurer le lien avec les autorités compétentes. Cette vision transverse m'a permis de développer une maîtrise rigoureuse du Règlement (UE) 2017/745 (RDM) et des normes internationales (ISO 13485, ISO 14971).
About
**Who they are**
Dounia is a compliance professional with expertise in Research and Development (R&D) and Regulatory Affairs, currently serving as the Person Responsible for Regulatory Compliance (PRRC). Dounia is seeking to leverage a technical and normative background to support regulatory affairs departments.
**Expertise & scope**
* Piloting the design and development of medical devices from feasibility to industrialization.
* Anticipating technical, quality, and regulatory constraints throughout the product lifecycle.
* Managing and qualifying subcontractors.
* Developing and executing design verification and validation plans, protocols, and reports.
* Coordinating multidisciplinary teams, including internal staff, subcontractors, clients, and end-users.
* Preparing for industrialization and participating in process qualification.
* Contributing to the creation of technical documentation and submission dossiers for market authorizations.
* Ensuring compliance with European Union Regulation (EU) 2017/745 (MDR).
* Conducting scientific, regulatory, normative, and technological watch.
* Providing freelance training and consulting in process engineering, polymerization engineering, basic general chemistry, and chemical risk.
* Experience in teaching general chemistry, materials science, and polymers.
* Involved in R&D projects focused on developing functional coatings for textiles (opacity, impermeability, flame retardancy) and high-performance concrete using textile fibers.
**Reputation / proof points**
* Expertise in EU MDR 2017/745.
* Experience in preparing technical documentation for international market authorizations (CE, FDA).
Dounia is a compliance professional with expertise in Research and Development (R&D) and Regulatory Affairs, currently serving as the Person Responsible for Regulatory Compliance (PRRC). Dounia is seeking to leverage a technical and normative background to support regulatory affairs departments.
**Expertise & scope**
* Piloting the design and development of medical devices from feasibility to industrialization.
* Anticipating technical, quality, and regulatory constraints throughout the product lifecycle.
* Managing and qualifying subcontractors.
* Developing and executing design verification and validation plans, protocols, and reports.
* Coordinating multidisciplinary teams, including internal staff, subcontractors, clients, and end-users.
* Preparing for industrialization and participating in process qualification.
* Contributing to the creation of technical documentation and submission dossiers for market authorizations.
* Ensuring compliance with European Union Regulation (EU) 2017/745 (MDR).
* Conducting scientific, regulatory, normative, and technological watch.
* Providing freelance training and consulting in process engineering, polymerization engineering, basic general chemistry, and chemical risk.
* Experience in teaching general chemistry, materials science, and polymers.
* Involved in R&D projects focused on developing functional coatings for textiles (opacity, impermeability, flame retardancy) and high-performance concrete using textile fibers.
**Reputation / proof points**
* Expertise in EU MDR 2017/745.
* Experience in preparing technical documentation for international market authorizations (CE, FDA).
Additional information
This provider's experience spans the entire product lifecycle, from initial concept to market entry and post-market surveillance. Key strengths include integrating regulatory requirements early in the design phase (Design Control) and managing the technical documentation required for national and international market authorizations. The provider has a strong understanding of the EU Medical Device Regulation (MDR) and international standards such as ISO 13485 and ISO 14971. Their background also includes experience in R&D project management and teaching, indicating a solid foundation in scientific principles and educational delivery.
Key Highlights
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Serves as a Person Responsible for Regulatory Compliance (PRRC).
Source
“Actuellement Responsable Recherche et Développement (R&D) et Personne Chargée du Respect de la Réglementation (PRRC)”
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Expertise in EU Regulation 2017/745 (MDR).
Source
“Maitrise du Règlement EU 2017 / 745 (MDR)”
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Experience in preparing technical documentation for CE and FDA submissions.
Source
“➔Rédaction de la documentation technique et soumission pour l’obtention des autorisations de mise sur le marché international (CE, FDA...)”
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Involved in the full product development cycle from ideation to CE marking.
Source
“Au cours de mon parcours en R&D, j’ai piloté la conception de produits depuis la phase d’idéation jusqu’au marquage CE”
Certifications & Trust Signals
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Experience as PRRC for LAMATEM.
Source
“PRRC de LAMATEM : chargée de veiller au respect de la réglementation (PRRC) selon le Règlement européen EU 2017/745”
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Familiarity with international standards like ISO 13485 and ISO 14971.
Source
“une maîtrise rigoureuse du Règlement (UE) 2017/745 (RDM) et des normes internationales (ISO 13485, ISO 14971).”
Buyer Snapshot
Best for
- Medical device companies seeking PRRC support.
- Organizations needing assistance with EU MDR compliance.
- Firms requiring technical documentation for market authorization.
How engagement typically works
- Project-based support for specific regulatory tasks.
- Consulting on R&D and regulatory strategy.
- Training on regulatory compliance and technical subjects.
Typical deliverables
- Technical documentation packages.
- Design Control documentation.
- Post-Market Surveillance (PMS) plans.
- Regulatory submission dossiers.
- Training materials and sessions.
Good to know
- Best when requiring expertise in EU MDR and related standards.
- Suitable for projects involving new product development or market entry.
Status:
claimed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Named PRRC:
Yes
Availability Hours:
24/7 on-call
Device Classes Supported:
Class I, Class Is/Im/Ir
PRRC Qualification Summary:
Docteur en physico-chimie des matériaux et actuellement Responsable R&D / PRRC, je vous soumets ma candidature pour le poste de Responsable Affaires Réglementaires au sein de [Nom de l'Entreprise]. Mon profil combine une expertise scientifique de haut niveau et une maîtrise opérationnelle des exigences réglementaires européennes et internationales.
Mon doctorat m'a apporté une rigueur d'analyse et une compréhension profonde des interactions matériaux-tissus, des problématiques de dégradation et de la caractérisation chimique. Ces compétences sont aujourd'hui cruciales pour répondre aux exigences renforcées du Règlement (UE) 2017/745, notamment concernant la sécurité des composants et la justification scientifique des dossiers techniques.
En tant que Responsable R&D et PRRC, j'ai su transformer ces connaissances techniques en leviers de conformité :
Expertise Matériaux : Rédaction et validation des dossiers de biocompatibilité (ISO 10993) et des analyses de risques (ISO 14971).
Stratégie Réglementaire : Pilotage de la transition vers le RDM, supervision de la documentation technique et garantie de la conformité du SMQ (ISO 13485).
Interface Scientifique : Capacité à dialoguer avec les Organismes Notifiés et à défendre des arguments techniques complexes lors d'audits.
Ma double casquette de Docteur et de PRRC me permet d'appréhender le cycle de vie du produit avec une vision à 360°. Je ne vois pas le réglementaire comme une contrainte, mais comme un cadre stratégique permettant d'accélérer l'innovation sécurisée.
eudamed_reg_support
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Vigilance
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
Same day
Additional prrc_service Details
Device Classes Supported
Class I, IIa, IIb, III (implied by CE marking and MDR expertise)
Supports MDR
Yes
PRRC Qualification Summary
Doctorate in Physico-chemistry of materials, extensive experience as R&D Manager and PRRC, direct responsibility for regulatory compliance under EU 2017/745.
Regulatory Experience
Experience includes piloting product design from ideation to CE marking, managing technical documentation, post-market surveillance, and international submissions. Specific years not quantified but role as PRRC is current.
