Sr. Specialist, Medical Affairs

The Senior Specialist serves as a global medical affairs team member supporting New Product Development (NPD) and Sustaining activities for assigned division product portfolio. This position will also support Subject Matter Experts (SME) and Clinical Evaluators for relevant medical device and regulated healthcare software regulatory requirements when applicable [e.g. EU Medical Device Directive (MDD), EU Medical Device Regulation (MDR), etc.]. In addition, provide additional relevant support as needed. Critical to this role is global and regional clinical knowledge of medical devices, environments of care and data use as well as the ability to offer guidance for product development support. What you'll be doing Serve as the medical/clinical resource for both internal and external customers for sustaining and product development efforts. Develop and deliver medical/clinical input for technical and training documents, claims matrix, risk documentation, and EU MDD/MDR results. Collaborate with relevant teams, including Clinical SMEs, R&D, Marketing, and Medical Affairs, for evidence generation, clinical literature searches, and compliance with regulations and standard operating procedures. Participate in relevant EU MDD/MDR Core Team meetings, process and logistics planning, and support Clinical Evaluators as needed. Maintain up-to-date knowledge base for related Baxter Care Communication products and assume other duties and responsibilities as assigned by manager/supervisor. Demonstrate clinical core proficiency for related products. Contribute to development and review of risk documentation, early and late phase testing, and participate in development of claims matrix, identification in gaps, and development of evidence generation plan in collaboration with R&D, Marketing, and Medical Affairs organizations. Provide medical writing support for relevant EU MDD/MDR deliverables (i.e. CEP, CER, PMCF, SSCP) and collaborate with Deliverable Program Managers (DPM) for coordination and execution of EU MDD/MDR deliverables. Supports Clinical SMEs with relevant medical writing expertise for evidence generation (e.g. white papers, clinical studies, publication plan, etc.). Supports other miscellaneous projects, based on skills and credentials, as needed. Supports legal, regulatory, and quality requirements related to R&D and product lifecycle management.