CASY-MSCCN Jobs

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission. What you will do Provide technical and strategic feedback for regulatory decisions associated with medical device software (SaMD and SiMD), digital health, and cybersecurity aligned with applicable regulations and business needs. Research, analyze, summarize, and present sophisticated issues and Regulatory Intelligence for Leadership team and other colleagues to ensure portfolio decisions are optimized in a rapidly growing business. Act as the Regulatory Expert for assigned projects, utilizing technical expertise and experience to guide project direction, including persuasive arguments to influence cross-functional teams to accomplish the mission. Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize success of development projects. Support product development and sustaining engineering for software projects, including document review & feedback, providing appropriate design control requirements for differing development phases. Build new or improve existing processes and deliverables that allow team members to operate successfully during product development and sustaining engineering projects, ensuring process harmonization w/ external Baxter requirements and expectations. Negotiate pre-market issues with regulatory authorities and company stakeholders toward successful outcomes. Write / provide feedback on regulatory strategies for new product development and product and process change control including prioritised US and OUS markets. Prepare regulatory documentation and lead pre-market submissions to relevant authorities (e.g., pre-submissions, letters to file, significant change assessments, pre-submissions, 510(k)s, Canada medical device license applications). Technical File/Documentation creation, maintenance, and audit support. Optimally work with internal stakeholders and external regulatory authorities and other technical resources (e.g., FDA, Notified Body, Health Canada, external consultants). Supervise applicable regulatory requirements; assure compliance with internal and external standards. Conduct safety and security risk management activities: hazard analysis, threat modeling, risk analyses, identify and evaluate risk control measures for supported projects. Follow documented procedures for all activities related to the Company's Quality System. Support other areas of the Quality System and perform other tasks as defined by Management. Ensure, and support as needed, effective and efficient post-market surveillance (e.g., clinical evaluation reports, post-market surveillance reporting, health hazard assessments). Develop/advise company on pre-market clinical studies, participating in execution of studies, and preparing required regulatory submission documentation. Support as needed, the effective and efficient processing of any assigned CAPAs. Complete other duties as assigned. This is an individual contributor role. Duties and responsibilities do not include management of direct reports. What do you bring Bachelor's degree or equivalent in technical discipline, such as engineering, computer sc