Enterprise Architect Lead (Product Development & Regulatory Compliance)

Job Description

The Lead Enterprise Architect (Product Development & Regulatory Compliance) is responsible for developing a forward-looking technology strategy and roadmap for their assigned domain, which translates business vision and objectives into technology initiatives and investments which then can be collaboratively refined together with senior business and IT stakeholders to ensure that business and IT needs are fulfilled. To achieve this the Lead EA collaborates across EA domains and Global IT functions to contribute to the overall EA and Global IT mission. The Lead EA manages architecture resource to design and evolve the strategy and roadmap within their domain and deliver the architecture principles to support design and implementation.

“The job is conducted in line with our Core Values which are: Patient Focus, Integrity, Innovation, Impact and Empathy. Olympus is an equal opportunities employer championing a culture of equality, diversity and inclusion embedded throughout the organization and workforce.”

Job Duties

• Define a compelling architectural vision for the Product Development & Regulatory Compliance domain, which includes the following Olympus business functions: i) Research & Development, ii) Regulatory Affairs, iii) Quality Management and iv) Medical & Scientific Affairs.
• Support the creation of business strategies providing technology expertise and an understanding of MedTech industry technology trends and best practice to inform business.
• Develop a clear business-led technology strategy and roadmap for the Product Development & Regulatory Compliance domain, ensuring alignment to the overall Global IT technology strategy and roadmap.
• Supports the Head of Enterprise Architecture in making strategic choices about the specific technologies Olympus will use (e.g., build vs buy etc.).
• Ensure alignment between the Product Development & Regulatory Compliance domain technology roadmap and the current and future priorities of Olympus.
• Monitor emerging technologies and assess their suitability for Olympus.
• Inputs into an up-to-date, forward-thinking innovation agenda for Olympus, specific to the Product Development & Regulatory Compliance domain.
• Provide Enterprise Architecture inputs and advice for Business Case development (technology, people, and processes).
• Provide Architecture Subject Matter Expert (SME) oversight for the Product Development & Regulatory Compliance domain.
• Create and develop a domain reference architecture for the Product Development & Regulatory Compliance domain, influencing the overarching Olympus reference architecture.
• Collaborate with R&D team(s) to understand technology needs for experimental design, data analysis, and simulation and develop IT strategies that support accelerated product development based on their needs. Evaluate emerging technologies such as artificial intelligence and machine learning for predictive modeling and data analytics in R&D.
• Collaborate with Regulatory Affairs team(s) to align the IT architecture to facilitate regulatory submissions, document management, and compliance tracking and to ensure adherence to global regulatory standards.
• Collaborate with Quality Management team(s) 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 team(s) to define IT architecture for medical evidence generation, clinical trials management, adverse event reporting, and medical information dissemination.
• Manage the demand and resourcing for their domain architecture team, understanding the architectural capability required to deliver solutions and manage resources.
• 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; developing ongoing relationships to maximize the value they deliver to Olympus, and ensuring Olympus is undertaking business on the best possible 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 Product Development & Regulatory Compliance 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 (The Open Group Architecture Framework), Zachman, etc. Experience in the Medical Technology industry, either in a MedTech company or in 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.
• Demonstrable organizational skills.