&D and Regulatory Affairs. · Support MDR and MDSAP readiness by ensuring product data, IFUs, and labelling are market-appropriate.... · Strong understanding of MDR and clinical evidence requirements. · Excellent written and verbal communication skills, with the ability...
Knowledge, Skills and Abilities Working knowledge of ISO 13485, 2017/745 (MDR) and 21 CFR Part 820 is essential Expertise..., and USP standards for drug delivery Knowledge of applicable health authority regulations including FDA, MDR Ability...
specifications in collaboration with R&D and Regulatory Affairs teams. Ensure compliance with MDR and MDSAP requirements... in European markets. Strong knowledge of MDR and clinical evidence requirements. Exceptional communication skills, both written...
operations Experience in medical devices with specific understanding of MDR’s Knowledge and experience in application...
relevant international standards (ISO 13485, FDA, MDR) to ensure compliance. Support the supply chain team with supplier...