Quality & Regulatory Affairs EMEA

Join Team Schein In A Meaningful Emea Quality & Regulatory Affairs Role Partner across countries and functions to ensure compliance, support product readiness, and help deliver trusted healthcare solutions that make a real difference. Your responsibilities will include:

• Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System.
• To provide comprehensive managerial and strategic ensuring efficient daily operations, effective communication, and seamless regional management of quality-related projects, compliance, and reporting.
• Supports to perform quality & regulatory visits and/or audits to countries and issues gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions.
• Participates to EMEA QA/RA Management meetings, issues minutes and follows-up on decided actions with related functional / country QA/RA Lead.
• Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up of identified actions.
• Driving & supporting multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives.
• Provides support to the PRRC of the EC Rep in Germany for Henry Schein Products by
• Review Quality Agreements to ensure responsibilities of economic operators (Importer/Distributor) are clearly addressed.
• Provides support to the Spanish QA/RA Team for Quality related topics to ensure compliance according GDP and MDR.

Your Qualification

• Bachelor's degree in Life Sciences, Pharmacist, Biomedical Engineering, or a related field with previous experience in Quality Management, Project Management, Medical Device and Pharmaceutical (GDP) experience is a plus
• Support Communicating with Regulatory Bodies MDR /IVDR Regulations/ ISO 13485
• Validation of (computerized systems) and Risk management (FMEA) knowledge is a plus
• Experience in Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR.
• You are solution oriented, have problem-solving attitude, and can be pragmatic, high adaptability and flexibility
• Ability to work in a matrix, regional environment with different departments and countries
• Fluency in English language and a good communication skills and stakeholder management

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