Supports EMEA-wide QA/RA operations, participating to EMEA QA/RA Management meetings, documenting EMEA policies, accompanying the Snr. Director QA/RA EMEA to perform quality visits to countries and issue gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions within the Integral Distribution Group Henry Schein Sites in EMEA.ESSENTIAL DUTIES AND RESPONSIBILITIES:Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System.Supports to perform quality & regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up and related documentation on identified issues and support countries in implementing solutions.Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up on decided actions with related functional / country QA/RA Lead.Support and assistance to Exec. Director QA & RA EMEA and the EMEA QA/RA TeamSupport to multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives.Maintenance of eQMS and Quality Document Management ToolOversight of change control activities and CAPA follow-up, timely closureProvides support to the country QA/RA Teams in Quality related topics to ensure compliance with GDP and MDR.Implementation of regulatory requirements and continuous improvement, support to ongoing transformation projects and product launch activitiesSupport roll-out eQMS implementation in identified countries.



o Inspection readiness initiatives and to roll- of required tools o Conduct and oversee quality training and compliance communications.Assists PRRC and EC Rep responsibilities such as adverse event reporting, post-market surveillance and FSN managementOther tasks and projects as neededPhysical Activities:Job holder based in any country in EMEAHome based – ready to travel regularly (up to 30%)QUALIFICATIONS:Experience:Quality Management, Project Management experiences, Medical DeviceExperiences, Pharmaceutical (GDP) experience is a plusMDR /IVDR Regulations/ ISO 13485Validation of (computerized systems) and Risk management (FMEA) knowledge is a plusEducation:Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, Business management or a related field.Specialised Knowledge and Skills:Knowledge and understanding of Quality Management Systems and Project ManagementQuality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR.Solution oriented, problem-solving attitude, pragmatic, high adaptability and flexibilityAbility to work in a matrix, regional environment with different departments and countriesEnglish speakerGood communication skills and stakeholder managementOther:Balances a sense of urgency of time pressures with adherence to all regulatory requirements.Sensitive in dealing with confidential InformationDemonstrates advanced oral and written communication skillsMust be fluent in written and spoken EnglishInformation on pay transparency pursuant to Directive (EU)



2023/970Please note that we comply with the relevant legal obligations regarding pay transparency, in particular those set forth in the EU Pay Transparency Directive (Directive (EU) 2023/970) and its respective national implementation.In this context, we will inform you of the starting salary or the corresponding salary range for the advertised position no later than before the first job interview or before a personal discussion of your application. This information is based on objective, gender-neutral criteria established for the position in question.Please note that we will not ask about your current or previous salary during the rest of the process in order to ensure equal pay.This notice does not constitute a claim to the conclusion of an employment contract or to a specific salary.Information on pay transparency in accordance with Directive (EU) 2023/970Please note that we comply with the relevant legal obligations regarding pay transparency, in particular those set forth in the EU Pay Transparency Directive (Directive (EU) 2023/970) and its respective national implementation.In this context, we will inform you of the starting salary or the corresponding salary range for the advertised position no later than before the first interview or before a personal discussion of your application. This information is based on objective, gender-neutral criteria established for the position in question.Please note that, to ensure equal pay, we will not ask about your current or previous salary at any later stage of the process.This notice does not constitute a guarantee of an employment contract or of a specific salary.#J-18808-Ljbffr

📌 Senior Specialist Quality & Regulatory Affairs Emea (Madrid)
🏢 Henryschein
📍 Madrid