Senior Specialist, Quality & Regulatory Affairs

🔥 0 minutes ago

🌐 Germany, United Kingdom, +3 more countries – Remote

🇩🇪 Germany – Remote 🇬🇧 United Kingdom – Remote 🇮🇹 Italy – Remote 🇫🇷 France – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.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.

Apply Now

Find Similar Remote Jobs

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 • Participate in EMEA QA/RA Management meetings and document EMEA policies • Support implementation of the EMEA Quality Management System • Perform quality and regulatory visits or audits to countries and issue gap analyses • Ensure CAPA follow-up and documentation, and support countries in implementing solutions • Organize virtual, onsite, and offsite regional meetings, including logistics and agendas • Support the Executive Director QA & RA EMEA and the EMEA QA/RA Team • Support multiple projects, track timelines, and ensure successful outcomes for EMEA-wide initiatives • 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 GDP and MDR compliance, regulatory implementation, continuous improvement, transformation projects, and product launches • Support eQMS implementation rollouts in identified countries • Support inspection-readiness initiatives and rollout 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, Project Management, and Medical Devices • 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 • Ability to work in a matrix regional environment with different departments and countries • Fluent written and spoken English • Good communication and stakeholder-management skills • Ability to balance time pressures with regulatory requirements • Ability to handle confidential information • Advanced oral and written communication skills

🏖️ Benefits

• Work from home • Home-based role • Regular travel up to 30% • Virtual, onsite, and offsite regional meetings

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume