Manager Clinical Affairs Job Title Manager Clinical Affairs Job Description Job Title: Manager Clinical Affairs (Medical Office) - DXR Job Responsibilities: - Leads the team of Medical Write r s and supports in writing comprehensive and compliant Clinical Evaluation Documents (CEP, CER, State of the Art, PMCF Plan and Reports), and clinical sections of regulatory submissions, employing expert-level medical writing skills and adhering to internal procedures, templates, and external standards, regulations, and guidance. - Has deep level knowledge of EU MDR ( Regulation (EU) 2017/745 ) - Analyzes clinical trial protocols and studies , ensuring adherence to regulatory requirements and alignment with strategic objectives , providing recommendations for protocol optimization and enhancement . - Collaborates with multidisciplinary teams to develop robust clinical development strategies for New Product Introduction (NPI) projects and post-market initiatives, integrating inputs from stakeholder...