Senior Specialist Quality & Regulatory Affairs EMEA

Supports EMEA-wide QA/RA operations, participating to EMEA QA/RA Management meetings, documenting EMEA policies, accompanying the Snr. Director QA/RA EMEA to perform quality visits to countries and issue gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions within the Global Distribution Group Henry Schein Sites in EMEA. ESSENTIAL DUTIES AND RESPONSIBILITIES: Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System. Supports to perform quality & regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up and related documentation on identified issues and support countries in implementing solutions. Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up on decided actions with related functional / country QA/RA Lead. Support and assistance to Exec. Director QA & RA EMEA and the EMEA QA/RA Team Support to multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives. Maintenance of eQMS and Quality Document Management Tool Oversight of change control activities and CAPA follow-up, timely closure Provides support to the country QA/RA Teams in Quality related topics to ensure compliance according GDP and MDR. Implementation of regulatory requirements and continuous improvement, support to ongoing transformation projects