Stage - Assurance Qualité & Affaire Réglementaire Dispositifs Médicaux (H/F) at Withings

Issy-les-Moulineaux, Île-de-France, France

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Not SpecifiedCompensation

InternshipExperience Level

InternshipJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

En formation Bac+4/5 en Qualité & Réglementaire, biomédical ou équivalent
Appétence pour les activités qualité et réglementaires
Curiosité pour le domaine de la santé et des dispositifs électro-médicaux (Class IIa/IIb)
Force d'initiative et flexible dans un environnement en constante évolution
Rigoureux‧euse, autonome et curieux‧euse sur les sujets techniques et réglementaires
À l’aise pour communiquer des idées et échanger à l’oral avec des interlocuteurs variés
Pédagogie et appréciation des interactions pluridisciplinaires et multiculturelles
Forte capacité à la rédaction et structuration de documents
Rigoureux(se) et organisé(e)
Bon niveau d’anglais (écrit et oral)
Idéalement, premier contact avec l'ISO 13485 ou le MDR 2017/745

Responsibilities

Contribuer à obtenir et maintenir les homologations nécessaires (marquage CE, 510k, etc.) à l'exportation et à la commercialisation des produits sur les marchés cibles, notamment en constituant des dossiers techniques, des enregistrements complets et conformes
Suivre et répondre aux besoins qualité et réglementaires des équipes R&D et ventes
Contribuer au maintien et à la mise à jour du SMQ notamment en cas d’évolutions réglementaires et normatives
Participer à la veille réglementaire et à la gestion des actions associées
Gérer les processus de contrôle documentaire, de change control, d’actions correctives et préventives (CAPA)
Gérer et suivre les corrections des non-conformités liées aux audits
Contribuer à l’organisation et à la préparation des revues de direction
Contribuer à véhiculer la culture qualité au sein de l’entreprise, notamment en organisant et en animant les formations requises
Présenter ses activités et interventions lors des audits internes et/ou externes
Maintenance des systèmes de management de la qualité (SMQ) d'Impeto Medical

Skills

Key technologies and capabilities for this role

Quality Management SystemCE MarkingFDA 510kRegulatory AffairsCAPADocument ControlChange ControlAuditsRegulatory Watch

Questions & Answers

Common questions about this position

Is this position remote or on-site?

This is an on-site position.

What education level is required for this internship?

Candidates must be in a Bac+4/5 program in Quality & Regulatory, biomedical, or equivalent.

What key skills are needed for this role?

Required skills include rigor, autonomy, curiosity on technical and regulatory topics, strong communication and pedagogy in multidisciplinary settings, excellent writing and document structuring abilities, and good English proficiency (written and oral). Ideally, prior contact with ISO 13485 or MDR 2017/745.

What is the compensation or salary for this internship?

This information is not specified in the job description.

What makes a strong candidate for this internship?

Strong candidates show appetite for quality and regulatory activities, curiosity for health and electro-medical devices (Class IIa/IIb), initiative, flexibility, rigor, autonomy, strong communication and writing skills, and English proficiency, with ideal prior exposure to ISO 13485 or MDR.

Withings

Designs and manufactures smart health devices

About Withings

Withings focuses on digital health technology by creating smart health devices like the ScanWatch, which monitor health metrics such as steps, sleep patterns, heart rate, and oxygen saturation. These devices cater to health-conscious individuals, athletes, and content creators who want to track and enhance their health and fitness. Customers can buy products directly from the Withings website, with flexible payment options including pay-later plans and interest-free installments, along with a 30-day return policy for added convenience. The accompanying mobile app syncs with the devices to help users track long-term health trends, fostering engagement and loyalty. Withings distinguishes itself through its award-winning customer service and a global community of over 1 million users who support each other in their health journeys. The company's goal is to empower individuals to take control of their health through accessible technology and community support.

Issy-les-Moulineaux, FranceHeadquarters

2008Year Founded

$89.5MTotal Funding

SERIES_BCompany Stage

Consumer Software, Healthcare, Consumer GoodsIndustries

201-500Employees

Risks

Increased competition from AI-powered health devices could challenge Withings' market position.

Complexity and installation issues of Omnia mirror may deter potential buyers.

Regulatory scrutiny on new health solutions like BPM Vision may delay market entry.

Differentiation

Withings offers a comprehensive range of smart health devices, including the ScanWatch.

The Omnia smart mirror provides a 360-degree view of health, enhancing user engagement.

Withings' direct-to-consumer model with flexible payment options sets it apart in the market.

Upsides

AI integration in devices like Omnia enhances personalized health insights and user satisfaction.

Expansion into cardiovascular health with BPM Vision and Cardio Check-Up attracts health-conscious consumers.

Growing interest in at-home health monitoring boosts demand for Withings' smart devices.

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