Quality & Regulatory Affairs

Job not on LinkedIn

🕒 April 21

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 45%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• 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