Senior Specialist, Quality and Regulatory Affairs

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🔥 59 minutes ago

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Henry Schein

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1932

🏥 Healthcare

🍽️ Food & Beverage

🏭 Manufacturing

Healthcare • Food & Beverage • Manufacturing

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

• Support EMEA-wide quality assurance and regulatory affairs operations • Document EMEA policies and support implementation of the EMEA Quality Management System • Perform quality and regulatory visits and/or audits, issue gap analyses, and ensure CAPA follow-up and documentation • Support countries in implementing quality and regulatory solutions • Organize virtual, onsite, and offsite regional meetings, including logistics, agendas, and action follow-up • Support the Executive Director QA & RA EMEA and the EMEA QA/RA Team • Support multiple EMEA-wide projects, track timelines, and ensure successful outcomes • Maintain the eQMS and Quality Document Management Tool • Oversee change control activities and CAPA follow-up through timely closure • Support country QA/RA teams on quality topics and compliance with GDP and MDR • Implement regulatory requirements and continuous improvement initiatives • Support transformation projects and product launch activities • Support eQMS implementation roll-out in identified countries • Lead inspection readiness initiatives and roll-out of required tools • Conduct and oversee quality training and compliance communications • Assist PRRC and EC Representative responsibilities, including adverse event reporting, post-market surveillance, and FSN management • Travel regularly, up to 30%

🎯 Requirements

• Experience in quality management and project management • Medical device experience • Pharmaceutical/GDP experience is a plus • Knowledge of MDR/IVDR regulations and ISO 13485 • Knowledge of computerized-system validation and risk management (FMEA) is a plus • Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Business Management, or a related field • Knowledge and understanding of Quality Management Systems and Project Management • Experience implementing and maintaining quality-system processes to meet ISO 13485:2016, GDP, and MDR requirements • Solution-oriented, pragmatic, adaptable, and flexible approach • Ability to work in a matrix regional environment with different departments and countries • English speaker • Fluent written and spoken English • Strong communication and stakeholder-management skills • Ability to balance time pressures with regulatory requirements • Ability to handle confidential information • Advanced oral and written communication skills • Willingness and readiness to travel regularly, up to 30%

🏖️ Benefits

• Work From Home arrangement • Opportunity to work in a diverse and inclusive environment • Opportunities to develop and contribute authentically • Opportunities to give back to society and local communities • Reasonable accommodations available during the application process