Regulatory & Quality Coordinator

2 months ago

Lachine, Canada Surgmed Group Full time

**Description du poste**:
Le Groupe Surgmed est à la recherche d'un(e) coordonnateur(trice) à la qualité dévoué(e) et minutieux(se) pour soutenir notre gestionnaire à la réglementation et à la qualité dans le maintien et l'amélioration de nos systèmes de qualité et de réglementation. Ce rôle est crucial pour garantir la conformité aux normes de l'industrie et soutenir les objectifs globaux de gestion de la qualité.
- _
- Surgmed Group is seeking a dedicated and detail-oriented Quality Coordinator to support our Regulatory & Quality Manager in maintaining and improving our quality and regulatory systems. This role is crucial in ensuring compliance with industry standards and supporting the overall quality management objectives._

**Responsabilités principales**:

- Légaliser la documentation requise par les clients pour les ventes internationales.
- Répondre aux demandes des clients concernant les produits et la réglementation, en collaboration avec le gestionnaire à la réglementation et à la qualité pour compléter les accords de qualité.
- Aider à la préparation des audits et soutenir les exigences d'audit selon les directives du président et/ou du gestionnaire à la réglementation et à la qualité.
- Mettre à jour les dossiers techniques avec les informations des fournisseurs ou les changements d'entreprise, y compris les tests, les formulaires, la documentation, les étiquettes et les IFUs (instructions d'utilisation).
- Coordonner, compiler et maintenir les données pour les objectifs de gestion de la qualité.
- Effectuer des tâches réglementaires générales, y compris la révision, la classification des produits et autres tâches connexes.
- Soutenir les actions correctives et préventives, en particulier celles découlant des audits.
- Gérer les tâches administratives liées aux dossiers techniques, aux manuels de qualité et aux demandes de production.
- Surveiller et approuver les rapports de production/inspection pour les produits stériles et les dossiers récapitulatifs de production.
- Approuver les nouvelles étiquettes, les modifications ou les suppressions d'étiquettes et d'IFUs.
- Assister à la révision de l'enregistrement auprès de la FDA et effectuer toutes les inscriptions UDI requises.
- **Key Responsibilities**:_
- _Legalize documentation required by customers for international sales._
- _Respond to customer product and regulatory inquiries, collaborating with the Regulatory & Quality Manager to complete quality agreements._
- _Assist in audit preparation and support audit requirements as directed by the President and/or Regulatory & Quality Manager._
- _Update technical files with supplier information or company changes, including testing, forms, literature, labels, and IFUs._
- _Coordinate, compile, and maintain data for quality management objectives._
- _Perform general regulatory duties, including product review, classification, and other related tasks._
- _Support corrective and preventive actions, particularly those arising from audits._
- _Handle administrative tasks related to technical files, quality manuals, and production requests._
- _Monitor and approve production/inspection reports for sterile products and production summary records._
- _Approve new labels, modifications, or deletions of labels and IFUs._
- _Assist with FDA registration review and perform all UDI registrations as required._

**Qualifications**:

- Maîtrise de l'anglais, tant à l'écrit qu'à l'oral ; la compréhension du français est un atout.
- Expérience et formation en ISO 13485, avec maîtrise des fonctionnalités et des normes ISO.
- Sens du détail avec de solides compétences organisationnelles et en gestion du temps.
- Expérience avec Microsoft Office, en particulier Excel et Outlook.
- À l'aise avec la terminologie médicale et les tâches basées sur la recherche.
- Excellentes compétences interpersonnelles, verbales et écrites.
- Fait preuve d'initiative, de bon jugement et d'une attitude positive.
- Compétences de dactylographie solides.
- Minimum de 2 ans d'expérience pertinente.
- **Qualifications**:_
- _Fluent in English, both written and spoken; French comprehension is an asset._
- _Experience and training in ISO 13485 with ISO functionality & Standards._
- _Detail-oriented with strong organizational and time management skills._
- _Experienced in Microsoft Office, with a focus on Excel and Outlook._
- _Comfortable with medical terminology and research-driven tasks._
- _Excellent interpersonal, verbal, and written communication skills._
- _Demonstrates initiative, good judgment, and a positive attitude._
- _Strong typing skills._
- _Minimum of 2 years of relevant experience._

**Environnement de travail**:

- Il s'agit d'un poste au bureau situé à Lachine, Québec.
- 37,5 heures par semaine, du lundi au vendredi. Horaires flexibles.
- **Work Environment**:_
- _This is an in-office position located in Lachine, Quebec._
- _37.5 hours a week,

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