Quality & Regulatory Affairs

🕒 April 21

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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 and documents EMEA policies • Supports to perform quality & regulatory visits and/or audits to countries and issues gap analysis • Ensures CAPA follow-up on identified issues and supports countries in implementing solutions • Participates in EMEA QA/RA Management meetings, issues minutes and follows-up on decided actions • Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and follow-up on identified actions • Driving & supporting multiple projects, tracking timelines, 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 reviewing Quality Agreements

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or a related field • Previous experience in Quality Management, Project Management, Medical Device and Pharmaceutical (GDP) experience is a plus • 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. • Solution oriented, pragmatic, high adaptability and flexibility • Ability to work in a matrix, regional environment with different departments and countries • Fluency in English language and good communication skills and stakeholder management

🏖️ Benefits

• Work from Home • Professional development opportunities