Quality & Regulatory Affairs EMEA
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-reputed company projects, compliance, and reporting.
Supports to reputed company 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 reputed company functional / country QA/RA reputed company.
Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and reputed company 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 reputed company 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 reputed company topics to ensure compliance according GDP and MDR.
Your Qualification
Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or a reputed company 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