**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-levelmedical writing skills andadhering to internal procedures, templates, and external standards, regulations, and guidance.
- Hasdeep levelknowledge of **EU MDR (** **Regulation (EU) 2017/745** )
-Analyzes **clinical 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 developmentstrategiesfor New Product Introduction (NPI) projects and post-market initiatives, integrating inputs from stakeholders such as Market...