Enterprise Architect (Product Development & Regulatory Compliance)
Olympus Corporation of the Americas
Summary
The Enterprise Architect (Product Development, Regulatory & Compliance) shapes and governs the domain architecture that enables faster, safer, and AI-enabled product innovation while ensuring sustained regulatory compliance. The role defines target-state capabilities, reference architectures, and multi-year transformation roadmaps across the end-to-end product lifecycle—from idea-to-market through post-market surveillance.
Job description
Technology Roadmap
- Co-create the domain target architecture and multi-year roadmap with business and IT leadership for Product Development and Regulatory & Compliance (QARA), aligned to enterprise strategy, value streams, and measurable outcomes.
- Drive product lifecycle digital thread thinking (requirements, design controls, risk, verification/validation, change control, submissions, post-market) and define the enabling capability map and reference architectures.
- Continuously scan MedTech/Life Sciences trends (cloud/SaaS, data platforms, AI, automation, digital quality, interoperability standards) and translate opportunities into actionable architecture options and investment recommendations.
- Provide architecture input to business cases and portfolio planning, including total cost of ownership, risk posture, validation/assurance effort, and change impact.
- Contribute to an innovation agenda for the domain, prioritizing scalable platforms and reusable capabilities over point solutions while respecting regulatory and quality constraints.
Domain Architecture
- Architect and evolve the domain landscape across R&D/PLM, Quality Management Systems (QMS/eQMS), Regulatory Information Management (RIM), document/records management, training, audit, and supplier quality—ensuring coherent end-to-end processes and data flows.
- Translate business capabilities and requirements into architecture decisions (build/buy, SaaS/platform fit, integration patterns, data ownership), balancing speed, compliance, and operational resilience.
- Define and maintain domain reference architectures, standards, and reusable patterns (API-first integration, event-driven patterns where appropriate, master/reference data patterns, and document-centric workflows).
- Ensure solutions meet regulated requirements and quality expectations (e.g., GxP, 21 CFR Part 11/Annex 11, ISO 13485, ISO 14971), including auditability, traceability, and electronic records/signatures.
- Embed Computer System Validation (CSV) / Computer Software Assurance (CSA) principles into solution design, delivery ways-of-working, and vendor management, in partnership with Quality and validation teams.
- Partner with cybersecurity, privacy, and data governance to ensure security-by-design, compliant data handling, and appropriate controls across cloud and on-prem environments.
- Guide solution teams through architecture reviews and key design decisions, resolving cross-domain dependencies and enabling interoperability with ERP, manufacturing, clinical, and customer/post-market systems as required.
Architecture Standards
- Define, socialize, and uphold domain architecture guardrails and standards (application, integration, data, identity/access, logging/audit, validation, and vendor/SaaS controls), aligned to enterprise policies and the regulated context.
- Run or support architecture governance for the domain (decision records, reference architectures, technology standards, and exception handling) and ensure traceability from business need to design decisions.
- Promote modern engineering and operating practices (product-centric delivery, platform thinking, automation, observability, and resilience) while maintaining compliance, validated state, and audit readiness.
Cloud, SaaS, AI & Automation Governance
- Govern adoption of cloud and SaaS platforms for regulated workloads, including configuration control, validation, and operational resilience.
- Define architecture for AI-enabled and automated systems, ensuring transparency, explainability, and regulatory alignment.
- Promote automation across the lifecycle (validation, testing, reporting, compliance monitoring).
- Evaluate emerging technologies and define safe adoption patterns in regulated environments.
Requirements
- Bachelor’s degree or higher in Computer Science, Engineering (or equivalent and related experience)
- Extensive experience with architectural frameworks such as TOGAF, Zachman, etc.
- Broad experience in software engineering and design architecture (certification preferred)
- 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
- Knowledge of technology integrations
- Understanding of technology security and regulatory requirements
- Understanding of technology trends
- Demonstrable business and tech acumen
- Detail orientated
- Minimum 7 years' experience as an Enterprise Architect with touchpoints in R&D, Quality Management, and regulatory compliance preferred
- Experience in the Medical Technology industry, either in a MedTech company or in a Life Science Consulting company preferred
Benefits
- Competitive Salaries
- Annual Bonus
- 401(k) Matching
- Medical, Dental & Vision
- Employee Assistance Program
- Wellbeing Programs
- Paid Vacation & Sick Time
- Paid Parental Leave
- Adoption Assistance
- 12 Paid Holidays
- On-Site Child Daycare
- Café
- Fitness Center
- Paid Volunteering
- Charitable Donation Match
- Employee Resource Groups
- Training & Development
- Paid Educational Assistance
Company overview
Olympus Corporation of the Americas is a leading global medical technology company and a wholly owned subsidiary of Olympus Corporation, headquartered in Center Valley, Pennsylvania. As a pioneer in the medical device industry, Olympus specializes in developing and manufacturing advanced endoscopic solutions, minimally invasive surgical equipment, and diagnostic imaging systems. The company holds approximately 70% of the global endoscope market, with a comprehensive portfolio that includes gastrointestinal endoscopes, laparoscopes, bronchoscopes, urological devices, and video imaging platforms. With over 5,200 employees across North and South America, Olympus focuses on creating innovative medical technologies that enable early detection, diagnosis, and minimally invasive treatment of diseases. The company's products are used across multiple medical specialties including gastroenterology, pulmonology, urology, and general surgery, helping healthcare professionals improve clinical outcomes while reducing procedural costs. Olympus continues to invest heavily in research and development, digital healthcare solutions, and AI-powered diagnostic tools to maintain its leadership position in the medical technology sector.