Henry Schein

Quality & Regulatory Affairs – EMEA

Henry Schein

full-time

Posted on:

Location Type: Remote

Location: Germany

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About the role

  • Supports EMEA-wide QA/RA operations, documenting EMEA policies and providing support to implement the EMEA Quality Management System.
  • Ensure efficient daily operations, effective communication, and seamless regional management of quality-related projects, compliance, and reporting.
  • Perform quality & regulatory visits and/or audits to countries and issue gap analysis, ensuring CAPA follow-up on identified issues and supporting countries in implementing solutions.
  • Participate in EMEA QA/RA Management meetings, issue minutes, and follow-up on decided actions with the related functional/country QA/RA Lead.
  • Organize virtual, onsite, and offsite regional meetings, including logistics, agendas, and close follow-up of identified actions.
  • Drive & support multiple projects, track timelines, and ensure successful outcomes for EMEA-wide QA/RA initiatives.
  • Provide support to the PRRC of the EC Rep in Germany for Henry Schein Products by reviewing Quality Agreements to ensure responsibilities of economic operators (Importer/Distributor) are clearly addressed.
  • Provide support to the Spanish QA/RA Team for Quality related topics to ensure compliance according to GDP and MDR.

Requirements

  • Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or a related field
  • Previous experience in Quality Management
  • Project Management experience
  • Knowledge of Medical Device and Pharmaceutical (GDP) regulations is a plus
  • Communicating with Regulatory Bodies
  • Knowledge of MDR /IVDR Regulations/ ISO 13485
  • Validation of computerized systems
  • Risk management (FMEA) knowledge is a plus
  • Experience in Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR.
  • Ability to work in a matrix, regional environment with different departments and countries
  • Fluency in English and good communication skills and stakeholder management.
Benefits
  • Health insurance
  • Remote work options
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality ManagementProject ManagementMedical Device regulationsPharmaceutical regulationsMDR regulationsIVDR regulationsISO 13485Validation of computerized systemsRisk managementQuality System process implementation
Soft Skills
Effective communicationStakeholder managementOrganizational skillsAbility to work in a matrix environmentFollow-up skillsMeeting facilitationTeam collaborationProblem-solvingAttention to detailAdaptability
Certifications
Bachelor’s degree in Life SciencesPharmacistBiomedical Engineering