Quality & Regulatory Affairs EMEA
Hybrid · Neu-Isenburg, Hesse, Germany
Job Summary
EMEA Quality & Regulatory Affairs role supporting QA/RA operations and policy documentation across multiple countries. Responsibilities include managing EMEA-wide QA/RA activities, supporting the EMEA Quality Management System, coordinating quality and regulatory visits/audits, conducting gap analyses, ensuring CAPA follow-up, participating in QA/RA leadership meetings, organizing regional meetings, and driving multiple projects to successful outcomes. Provides support to the PRRC of the EC Representative in Germany for Henry Schein products, supporting Spain’s QA/RA topics to ensure GDP/MDR compliance, and collaborating within a matrix regional environment. The role emphasizes documentation, cross-country collaboration, project coordination, and ensuring regulatory compliance across Europe, with emphasis on ISO 13485, GDP, and MDR requirements. English fluency and strong stakeholder management are essential.
Required Qualifications
- Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or related field
- previous experience in Quality Management, Project Management, Medical Device and Pharmaceutical (GDP) experience a plus
- Experience in Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR is a plus
- Ability to work in a matrix, regional environment with different departments and countries
- Fluency in English and strong communication and stakeholder management skills
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