Ingénieur en conformité (opérations réglementaires)
Contracter: Santa Clara, Californie, États-Unis
Échelle des salaires: 50.00 - 52.00 | Par heure
Code du travail: 358023
Date de fin: 2025-02-22
Statut d'emploi: Expiré
Cet emploi n'accepte plus de candidatures
Aperçu du rôle:
- Provide compliance support to the Regulatory Affairs (RA) team by:
- Creating KPI dashboards and monitoring RA management reviews and metrics.
- Managing RA audit preparedness, including risk identification and mitigation.
- Supporting quality system integration for acquisitions and new products.
- Identifying and implementing systemic process improvements.
- Tracking and maintaining regulatory post-approval commitments.
- Driving quality system process improvements.
Initiatives clés :
- Establish audit support for integration products.
- Enhance and maintain quality system procedures.
- Collaborate with cross-functional and international teams for audit compliance.
- Participate in audit backrooms and RA projects.
Tâches principales :
- Track and close RA change requests.
- Manage change processes.
- Develop and implement audit plans for critical RA tasks.
- Manage CAPAs and audit findings.
- Oversee post-approval commitments.
- Support RA perspective in QMS audits and integration tasks.
- Present management review metrics results.
Obligatoire:
- BS requird.
- 5-7 year of experience required.
Gamme de paiement:
- 50 $ à 52 $/heure
Exigence d'emploi
- CAPA
- audit
- SMQ
- Système de qualité
- Affaires Réglementaires
- Audit RA
- Veeva
Contactez un recruteur
- Recruteur
- Téléphone
- Sanjay Rawat
- sanjay.rawat@collabera.com
Cet emploi n'accepte plus de candidatures
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