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Posted 2w ago

Quality & Regulatory Affairs EMEA

@ Henry Schein
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Langen, Hesse, Germany
RemoteFull Time
Responsibilities:organize meetings, conduct audits, manage projects
Requirements Summary:Lead EMEA QA/RA activities, ensure ISO 13485/GDP/MDR compliance, support PRRC, manage projects and audits.
Technical Tools Mentioned:ISO 13485, GDP, MDR, FMEA, CAPA, Validation, ISO 14971
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Job Description

  • Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System.

  • To provide comprehensive managerial and strategic ensuring efficient daily operations, effective communication, and seamless regional management of quality-related projects, compliance, and reporting.

  • Supports to perform quality & regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions.

  • Participates to EMEA QA/RA Management meetings, issues minutes and follows-up on decided actions with related functional / country QA/RA Lead.

  • Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up of identified actions.

  • Driving & supporting multiple projects, tracking timelines, and 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

  • Review Quality Agreements to ensure responsibilities of economic operators (Importer/Distributor) are clearly addressed.

  • Provides support to the Spanish QA/RA Team for Quality related topics to ensure compliance according GDP and MDR.

Your Qualification

  • Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or a related field with previous experience in Quality Management, Project Management, Medical Device and Pharmaceutical (GDP) experience is a plus

  • Support 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.

  • You are solution oriented, have problem-solving attitude, and can be pragmatic, high adaptability and flexibility

  • Ability to work in a matrix, regional environment with different departments and countries

  • Fleuncy in English language and a good communication skills and stakeholder management