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.
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
Fleuncy in English language and a good communication skills and stakeholder management
Skills Required
- Bachelor's degree in Life Sciences, Pharmacist, Biomedical Engineering or a related field
- Experience in Quality Management and Project Management in Medical Device and Pharmaceutical
- Fluency in English with good communication skills and stakeholder management
- Knowledge of MDR /IVDR Regulations and ISO 13485
- Experience in quality system process implementation and maintenance to meet ISO 13485:2016
What We Do
Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With more than 20,000 Team Schein Members worldwide, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. Our Business, Clinical, Technology, and Supply Chain solutions help office-based dental and medical practitioners work more efficiently so they can provide quality care more effectively. These solutions also support dental and medical laboratories, government and institutional healthcare clinics, as well as other alternate care sites.
