Quality & Regulatory Affairs EMEA

Join Team Schein in a meaningful EMEA Quality & Regulatory Affairs role where collaboration, integrity, and continuous improvement come together. You'll 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.

• 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
  
• Fleuncy in English language and a good communication skills and stakeholder management