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. Job Duties 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 MedTech 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. Job Qualifications 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 regulatory compliance. Extensive experience with architectural frameworks such as TOGAF, Zachman, etc. Experience in the Medical Technology industry, either in a MedTech company or a Life Science Consulting company preferred. Extensive experience in software engineering and design architecture. Significant experience in defining architecture policies and frameworks. Advanced understanding of business analysis techniques and processes. Knowledge and experience in project management, process modelling, data modelling and systems analysis. Demonstrable knowledge of contributing to business‑aligned Technology strategies. Expert knowledge of technology integrations. Understanding of technology security and regulatory requirements. Understanding of technology trends. In‑depth knowledge of working with business processes in the assigned domain, preferably in medical related fields. Demonstrable business and tech acumen. Equitable Offerings you can count on: Competitive salaries, annual bonus and 401(k) with company match 24/7 Employee Assistance Program Free live and on‑demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance 12 Paid Holidays On‑site Child Daycare, Café, Fitness Center Connected Culture you can embrace: Work‑life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs The anticipated base pay range for this full‑time position is $144,541.00-$216,812.00 per year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. If reasonable accommodation is needed, please contact View email address on click.appcast.io or call View phone number on click.appcast.io. Equal Employment Opportunity It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin, citizenship status, religious creed, age, sex, gender identity and expression, sexual orientation, marital status, disability, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. #J-18808-Ljbffr Olympus Corporation of the Americas