Manager Clinical Affairs

Job Title

Job Description

Job Title: Manager Clinical Affairs(Medical Office)- DXR

Job Responsibilities:

- Leads the team of Medical Writers andsupports in writingcomprehensive and compliant Clinical EvaluationDocuments (CEP, CER, State of the Art, PMCF Plan and Reports),and clinical sections of regulatory submissions, employing expert-levelmedical writing skills andadhering to internal procedures, templates, and external standards, regulations, and guidance.

- Hasdeep levelknowledge ofEU MDR (Regulation (EU) 2017/745 )

-Analyzesclinical trial protocols and studies , ensuring adherence to regulatory requirements and alignment with strategicobjectives, providing recommendations for protocol optimization and enhancement.

-Collaborates with multidisciplinary teams to develop robust clinical developmentstrategies...