Senior Specialist Quality & Regulatory Affairs EMEA

Job description

Join Team Schein in a meaningful EMEA Quality & Regulatory Affairs role where collaboration, integrity, and continuous improvement come together. You’ll 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: 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 Information on pay transparency pursuant to Directive (EU) 2023/970 Please 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.