Job Description

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. Responsibilities include serving as the medical/clinical resource for both internal and external customers for sustaining and product development efforts; developing and delivering medical/clinical input for technical and training documents, claims matrix, risk documentation, and EU MDD/MDR results; collaborating with relevant teams including Clinical SMEs, R&D, Marketing, and Medical Affairs for evidence generation, clinical literature searches, and compliance with regulations and SOPs; participating in relevant EU MDD/MDR Core Team meetings, process and logistics planning, and supporting Clinical Evaluators as needed; maintaining up-to-date knowledge base for related Baxter Care Communication products; demonstrating clinical core proficiency for related products; contributing to development and review of risk documentation, early and late phase testing, and development of claims matrix and evidence generation plans; providing medical writing support for relevant EU MDD/MDR deliverables and collaborating with Deliverable Program Managers; supporting Clinical SMEs with medical writing expertise for evidence generation; supporting miscellaneous projects based on skills and credentials; and supporting legal, regulatory, and quality requirements related to R&D and product lifecycle management. Requirements include a degree in nursing, nursing informatics, or other clinical subject area with relevant experience; 3+ years of acute adult medical surgical, intensive care or related clinical experience; specialty certification preferred; active license in a U.S. state or territory in good standing; ability to travel domestically and internationally up to 50%; strong problem-solving and resolution skills; sound scientific clinical approach to medical writing; self-motivation with effective time management; advanced interpersonal and communication skills; and authorization to work for any employer in the U.S. without visa sponsorship. Baxter offers a flexible workplace policy with a required minimum number of days onsite, competitive salary, and comprehensive benefits.

By applying, you consent to your information being transmitted by Jooble to the Employer, as data controller, through the Employer’s data processor SonicJobs.
See BAXTER Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at

Job Tags

Similar Jobs