Quality & Regulatory Affairs – EMEA

🕒 April 16

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Henry Schein

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1932

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🤝 B2B

Healthcare Insurance • Pharmaceuticals • B2B

Henry Schein is a global company dedicated to servicing a range of medical and dental providers. It offers a comprehensive portfolio of products and solutions, including practice management software, large equipment, and technology services. Founded in 1932, Henry Schein has established itself as a leader in healthcare products and services, with a commitment to improving health and increasing access to care through strategic growth and innovation across its global operations.

📋 Description

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

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or a related field • Previous experience in Quality Management • Project Management experience • Knowledge of Medical Device and Pharmaceutical (GDP) regulations is a plus • Communicating with Regulatory Bodies • Knowledge of MDR /IVDR Regulations/ ISO 13485 • Validation of computerized systems • Risk management (FMEA) knowledge is a plus • Experience in Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR. • Ability to work in a matrix, regional environment with different departments and countries • Fluency in English and good communication skills and stakeholder management.

🏖️ Benefits

• Health insurance • Remote work options