Enterprise Architect Lead; Product Development & Regulatory Compliance

Enterprise Architect Lead (Product Development & Regulatory Compliance)

Working

Location:

Massachusetts, Westborough;
California, San Jose;
Minnesota, Brooklyn Park;
Tennessee, Bartlett

Workplace Flexibility: Hybrid

The Lead Enterprise Architect (Product Development & Regulatory Compliance) is responsible for developing a forward‑looking technology strategy and roadmap for their assigned domain, translating business vision and objectives into technology initiatives and investments. This role collaborates across EA domains and Global IT functions, manages architecture resources, designs and evolves the strategy and roadmap, and delivers architecture principles to support design and implementation.

The Lead EA works with senior business and IT stakeholders to ensure that business and IT needs are fulfilled.

• Define a compelling architectural vision for the Product Development & Regulatory Compliance domain, which includes Research & Development, Regulatory Affairs, Quality Management, and Medical & Scientific Affairs.
• Support the creation of business strategies by providing technology expertise and an understanding of Med Tech industry technology trends and best practices.
• Develop a clear, business‑led technology strategy and roadmap for the domain, ensuring alignment with the overall Global IT technology strategy and roadmap.
• Support the Head of Enterprise Architecture in making strategic choices about the specific technologies Olympus will use (e.g., build vs. buy).
• Ensure alignment between the domain technology roadmap and the current and future priorities of Olympus.
• Monitor emerging technologies and assess their suitability for Olympus.
• Contribute to an up‑to‑date, forward‑thinking innovation agenda for Olympus, specific to the domain.
• Provide Enterprise Architecture inputs and advice for Business Case development (technology, people, and processes).
• Act as Architecture SME oversight for the domain.
• Create and develop a domain reference architecture for the domain, influencing the overarching Olympus reference architecture.
• Collaborate with R&D teams to understand technology needs for experimental design, data analysis, and simulation, and develop IT strategies that support accelerated product development. Evaluate emerging technologies such as AI and ML for predictive modeling and data analytics in R&D.
• Collaborate with Regulatory Affairs teams to align the IT architecture to facilitate regulatory submissions, document management, and compliance tracking, ensuring adherence to global regulatory standards.
• Collaborate with Quality Management teams to define IT strategies to enhance quality control processes, including automation of testing, validation, and release management.
• Ensure IT systems supporting quality assurance and quality control processes adhere to industry‑specific regulatory requirements.
• Collaborate with Medical & Scientific Affairs teams to define IT architecture for medical evidence generation, clinical trials management, adverse event reporting, and medical information dissemination.
• Manage the demand and resourcing for the domain architecture team, ensuring the architectural capability required to deliver solutions.
• Inform business owners for their domain(s) with options to influence decisions.
• Support the Head of Enterprise Architecture to identify future capabilities the function will require to support the business.
• Establish and manage domain relationships with technology suppliers; develop ongoing relationships to maximize value and ensure Olympus obtains the best commercial terms.
• Work closely with other Lead EAs to define common architecture and solutions where applicable.
• Define and uphold the Enterprise Architecture guardrails for the domain.
• Ensure the delivery of high‑level design and assuring the output adheres to the Enterprise Architecture guardrails.
• Coordinate and drive automation, new ways of working and tooling across delivery.

Required:

• Bachelor’s degree or higher in Computer Science, Engineering (or equivalent and related experience preferred).
• Minimum 10 years’ experience as an Enterprise Architect with touchpoints in R&D, Quality Management, and…