Course Lecturer

3 weeks ago

Montréal, Canada McGill University Full time

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DESCRIPTION DU COURS

Aperçu du cours : Génie biomédical : les stratégies réglementaires et les systèmes de gestion de la qualité sont essentiels au développement de dispositifs médicaux. Ce cours donne un aperçu des exigences réglementaires et familiarise les étudiants avec les importantes normes ISO et CEI relatives au développement de dispositifs médicaux. Ce cours fournira aux ingénieurs biomédicaux une compréhension des exigences réglementaires et de qualité pour traduire une idée de dispositif médical en un produit commercial, et s'appuiera sur l'expertise des conférenciers invités travaillant actuellement dans l'industrie des dispositifs médicaux.

Responsabilités

Préparer les étudiants avec les connaissances requises, faciliter les discussions en classe, évaluer et évaluer le rendement des étudiants et préparer les étudiants à devenir des leaders prospères dans leur profession.

Les autres principales responsabilités comprennent:

- Préparation des cours magistraux et des supports pédagogiques
- Préparation des devoirs, des tests et des grilles de notation
- Participation aux discussions curriculaires
- Tenir des heures de bureau régulières

Exigences de qualification d'enseignement

1) Comprendre les exigences de la FDA et de Santé Canada pour les dispositifs médicaux.

2) Comprendre les meilleures pratiques requises pour l'autorisation réglementaire en temps opportun et l'entrée des dispositifs médicaux sur les marchés des États-Unis et du Canada.

3) Comprendre le rôle critique des systèmes qualité et de la gestion efficace des processus dans le processus d'innovation.

4) Comprendre les définitions, les concepts et les lignes directrices de la gestion de la qualité.

5) Comprendre les exigences des normes ISO 13485:2003, ISO 14971:2007 et CEI 62304:2006, ainsi que les réglementations du système qualité de la FDA (21CFR820).

Éducation

Baccalauréat en sciences, en génie ou en arts

Expérience

Plus de 5 ans dans la gestion de la qualité des dispositifs médicaux et les affaires réglementaires

Autre

Maîtrise de l'anglais et du français (écrit et oral) souhaitée

Comment s'inscrire

Les employés actuels de McGill doivent postuler via des affichages internes.

Ceux-ci sont accessibles à l'aide du rapport "Rechercher des emplois" dans Workday.

Clause de non-responsabilité
- Veuillez noter qu’en raison de la reprise des activités d’enseignement en personne, la plupart des cours seront offerts en format présentiel. Il se peut toutefois que les étudiants doivent passer leurs examens à distance en fonction principalement de la taille des classes. Les chargés de cours devront planifier en conséquence. Si les restrictions gouvernementales interdisent la reprise de l'enseignement en personne, les cours reviendront à l'enseignement à distance. Dans l'éventualité d'un tel changement, les chargés de cours en seront informés sans délai. Les chargés de cours peuvent être appelés à préparer et à présenter du matériel didactique adapté à un environnement d'enseignement à distance/en ligne en utilisant une plateforme d'apprentissage virtuelle (p. ex., Zoom, WebEx) et myCourses, le système de gestion de l'apprentissage de McGill. Les Services d’enseignement et d’apprentissage (TLS) offrent de la formation et de l’assistance en matière d’enseignement à distance. Les chargés de cours sont encouragés à enregistrer leurs cours._

Unité d’embauche:
Biomedical Engineering

Titre du cours:
Biomedical Regulatory Affairs-Medical Devices
-Code de sujet:


BMDE 654 001

Lieu:
Classroom (Duff 321)

Horaire:
Thursdays from 16:05 - 18:55
- Date limite pour postuler:
2023-06-15

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