Overview Join Our Innovative Team at Software Technology Solutions (STS)! Are you ready to be part of a groundbreaking team that is transforming healthcare through cutting-edge technology? Software Technology Solutions (STS) is BD’s global software innovation engine, driving smart connectivity and data-driven insights across devices. Our mission is to make a tangible difference in patients' lives with world-class technology capabilities. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Responsibilities Director, Software Process Excellence — Lead the strategic and operational aspects of software development processes for Quality Management System (QMS) and regulatory compliance. Ensure software products meet applicable regulatory, safety, and performance standards while fostering a culture of continuous quality improvement. Shape and implement the Software Development Lifecycle (SDLC) across the enterprise to deliver high-quality SaaS and multi-tenant cloud solutions. Cross-Functional Collaboration — Partner with Engineering, Product Management, Product Security, Legal, Regulatory, Quality Assurance, and Business Units to embed quality and regulatory requirements into the product lifecycle from concept through post-market. SDLC Development and Maintenance — Develop and maintain a comprehensive SDLC aligned with BD goals and regulatory requirements to enable frequent releases of cloud-based products. QMS Continuous Improvement — Lead and improve QMS processes in STS in compliance with relevant standards (e.g., ISO) and software standards. Regulatory Guidance — Define and own regulatory guidance and frameworks for software development in a healthcare IT environment, in coordination with Regulatory Affairs. Audit Oversight — Oversee internal and external audits with audit readiness and full traceability of documentation and actions. Compliance and Tools — Ensure regulatory and quality compliance; evaluate and implement tools and automation to streamline processes. Training and Development — Lead training and development of QA/RA teams to support a proactive, risk-based approach. Subject Matter Expert — Serve as primary contact for regulatory bodies, complaint handling, and quality/regulatory reporting as needed. Strategic Vision — Contribute to strategic direction with quality and regulatory thought leadership. Stakeholder Management — Build relationships with customers, partners, and internal teams; communicate progress to senior stakeholders; support BD software and cyber security programs. Agile Implementation — Champion agile software development methodologies across STS teams. Process Reviews — Conduct process reviews and implement improvements. Cultural Fit — Align with company culture and values. Qualifications Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field (Master’s or RAC certification preferred). 10+ years in Quality Assurance and Regulatory Affairs within the medical device or SaMD industry. Experience with FDA 510(k) and/or De Novo submissions, CE Marking, and global approvals. Strong understanding of risk management, software lifecycle validation, and design controls for medical device software. Healthcare industry experience is a plus. Familiarity with Agile methodologies (e.g., Scrum, Kanban) and SAFe. Strong teamwork, collaboration, and a results-driven mindset. Excellent communication and presentation skills; ability to bridge technical and business audiences. Ability to influence and partner with stakeholders at all levels; capable of leading multiple concurrent efforts. Hybrid in San Diego preferred; remote employees should be prepared to travel monthly to San Diego. For certain roles at BD, employment is contingent upon proof of full vaccination against COVID-19. In some locations, testing may be available or required. BD’s Workplace Accommodations Policy applies to requests for accommodation as required by law. Why Join Us? A career at BD means valuing your opinions and contributions, encouraging you to bring your authentic self to work, and supporting growth, accountability, and continuous learning. To learn more about BD visit https://bd.com/careers. Salary Range Information $179,200.00 - $322,500.00 USD Annual

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