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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