...Regulatory Affairs for the EDM Region within a team of regulatory experts. **Your main responsibilities*** Ensure regulatory compliance of pladis brands in accordance with the sale market regarding pr...
...regulatory submissions for SaMD and AI-enabled IVDs. Familiarity with ISO 13485 and medical device Quality Management Systems. Strong knowledge of regulatory frameworks for AI/ML (e.g., EU AI Act, US ...
...affairs, regulatory affairs, and sales and marketing teams, to ensure awareness and compliance with safety requirements. Participates in strategic initiatives to enhance the overall safety profile of ...
...regulatory compliance, smooth production processes, and timely market access. You will handle dossiers, artwork, and documentation, while also staying up to date with regulatory requirements in your a...
...compliance with regulatory requirements and quality standards, confirming that all IMPs are manufactured, tested, and documented in accordance with applicable guidelines.2. Quality Oversight and Compl...
...Regulatory AI & Digital Innovation Join to apply for the Director of Regulatory AI & Digital Innovation role at Philips. Role Purpose Transform IGTS Regulatory Affairs into an AI-powered, digitally en...
...regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business. Maintain required high level of product knowledge within defined portfolio, regulatory ...
...Regulatory Affairs & Quality Assurance zijn we op zoek naar een: Gaat jouw hart sneller kloppen van het coachen en motiveren van een team op het gebied van Product Regulatory and Quality in een intern...
...Regulatory Affairs for the EDM Region within a team of regulatory experts. **Your main responsibilities*** Ensure regulatory compliance of pladis brands in accordance with the sale market regarding pr...
...management tools in aspects across the quality management system, and product related elements to assess impact on product quality, and overall compliance with regulatory expectations and with the mar...
...quality and compliance from development through design transfer (hardware and software), collaborating closely with R&D. Partner with Manufacturing, R&D, Quality, Regulatory, suppliers, and CMOs to de...
...&D, CSR, Procurement, Quality and Regulatory Affairs at both group and local levelReport to the Group Regulatory Affairs & Raw Material Specifications Manager.PositionBachelor’s or master’s degree in ...
...regulatory affairs team, you will be responsible for the effective management and timely delivery of CMC regulatory documents, while maintaining compliance with global regulatory standards and commitm...
...Regulatory Affairs, Supply Chain, Customer Service, Quality Systems, Field Service, Manufacturing, and distribution centers to ensure seamless execution. Ensure global regulatory compliance by prepari...
...regulatory affairs (RA) manager will support regulatory submissions and compliance activities for clinical studies in the European Region and USA, with a focus on preparation of regulatory documents a...