Quality & Regulatory Affairs EMEA
Join Team Schein In A Meaningful Emea Quality & Regulatory Affairs Role
Partner across countries and functions to ensure compliance, support product readiness, and help deliver trusted healthcare solutions that make a real difference.
Your responsibilities will include:
ā¢ Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System.
ā¢ To provide comprehensive managerial and strategic ensuring efficient daily operations, effective communication, and seamless regional management of quality-related projects, compliance, and reporting.
ā¢ 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.
ā¢ Participates to EMEA QA/RA Management meetings, issues minutes and follows-up on decided actions with related functional / country QA/RA Lead.
ā¢ Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up of identified actions.
ā¢ Driving & supporting multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives.
ā¢ Provides support to the PRRC of the EC Rep in Germany for Henry Schein Products by
ā¢ Review Quality Agreements to ensure responsibilities of economic operators (Importer/Distributor) are clearly addressed.
ā¢ Provides support to the Spanish QA/RA Team for Quality related topics to ensure compliance according GDP and MDR.
Your Qualification
ā¢ 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
ā¢ Support Communicating with Regulatory Bodies MDR /IVDR Regulations/ ISO 13485
ā¢ Validation of (computerized systems) and Risk management (FMEA) knowledge is a plus
ā¢ Experience in Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR.
ā¢ You are solution oriented, have problem-solving attitude, and can be pragmatic, high adaptability and flexibility
ā¢ Ability to work in a matrix, regional environment with different departments and countries
ā¢ Fluency in English language and a good communication skills and stakeholder management
Apply tot his job
Apply To this Job
Partner across countries and functions to ensure compliance, support product readiness, and help deliver trusted healthcare solutions that make a real difference.
Your responsibilities will include:
ā¢ Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System.
ā¢ To provide comprehensive managerial and strategic ensuring efficient daily operations, effective communication, and seamless regional management of quality-related projects, compliance, and reporting.
ā¢ 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.
ā¢ Participates to EMEA QA/RA Management meetings, issues minutes and follows-up on decided actions with related functional / country QA/RA Lead.
ā¢ Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up of identified actions.
ā¢ Driving & supporting multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives.
ā¢ Provides support to the PRRC of the EC Rep in Germany for Henry Schein Products by
ā¢ Review Quality Agreements to ensure responsibilities of economic operators (Importer/Distributor) are clearly addressed.
ā¢ Provides support to the Spanish QA/RA Team for Quality related topics to ensure compliance according GDP and MDR.
Your Qualification
ā¢ 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
ā¢ Support Communicating with Regulatory Bodies MDR /IVDR Regulations/ ISO 13485
ā¢ Validation of (computerized systems) and Risk management (FMEA) knowledge is a plus
ā¢ Experience in Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR.
ā¢ You are solution oriented, have problem-solving attitude, and can be pragmatic, high adaptability and flexibility
ā¢ Ability to work in a matrix, regional environment with different departments and countries
ā¢ Fluency in English language and a good communication skills and stakeholder management
Apply tot his job
Apply To this Job