Quality & Regulatory Affairs – EMEA

Henry Schein

Supports EMEA-wide QA/RA operations at Henry Schein, ensuring quality management and compliance. Organizes regional meetings and drives multiple projects across countries.

Posted 4/16/2026full-timeRemote • 🇩🇪 GermanyMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Health insurance
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

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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