Regulatory Affairs Manager

This is an hybrid position requiring the team member to be onsite 3 days a week.   Who We Are: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?     There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.     We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.   Job Summary

The Manager, Regulatory Affairs Digital Health & Innovation provides strategic regulatory leadership for software-enabled medical devices, including Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and other emerging digital health solutions. This role serves as a regulatory subject matter expert for digital health product development and lifecycle management, with a strong focus on software-driven medical technologies, cybersecurity requirements, and regulatory strategy for digital health innovations. The Manager will partner closely with R&D, Digital & Technology, Quality, Product Management, and other cross-functional stakeholders to define regulatory pathways, interpret evolving requirements, support compliant product development, and enable timely regulatory submissions and lifecycle changes. In addition, this role will play a key role in advancing Regulatory Affairs digital transformation by identifying, shaping, and supporting the adoption of compliant AI-enabled tools, automation solutions, and RA-focused digital capabilities that improve productivity, scalability, data traceability, submission quality, and operational efficiency across Regulatory Affairs.  Essential Duties and Responsibilities

Lead the development and execution of regulatory strategies for software-enabled medical devices across the product lifecycle, including early product development, design changes, regulatory submissions, health authority interactions, and post-market lifecycle activities.  Partner with R&D, Digital & Technology, Quality, Product Management, and other subject matter experts to provide regulatory guidance and ensure applicable requirements are appropriately incorporated into software-enabled medical device design, development, risk management, usability, verification and validation, cybersecurity documentation, change management, and lifecycle management processes.  Support the expansion of internal Regulatory Affairs capabilities in digital health by developing and maintaining regulatory knowledge, best practices, templates, assessment tools, and internal guidance related to software, cybersecurity, AI-enabled technologies, and emerging digital health expectations.  Provide regulatory support for cybersecurity considerations across the digital health portfolio, including assessment of documentation needs, review of cybersecurity-related content, interpretation of regulatory expectations, and support for post-market cybersecurity considerations, as applicable.  Author, review, and support regulatory submission content and health authority responses related to software functionality, software architecture, software development processes, cybersecurity, risk management, verification and validation, and hardware/software integration.