Principal SaMD Learning Architect for Regulated Dev

Oracle; Nashville (TN); On-site; USD 91,000 - 187,000; Full time

Job summary

Oracle is seeking a Principal Technical Learning Consultant to design, build, and lead learning programs for regulated medical device software. This role focuses on translating regulatory, quality, and systems engineering concepts into practical, role-based experiences for engineers, product managers, TPMs, and quality professionals, supporting Oracle Health’s widespread product development.

You will create onboarding paths, certifications, and continuous education, while shaping learning

Qualifications

• Bachelor’s degree in a relevant field.
• 8 years of experience in medical device software, healthcare technology, quality engineering, systems engineering, regulatory affairs, product development, or technical learning.
• Experience in regulated healthcare/software environments (SaMD).
• Strong understanding of software development lifecycle processes.
• Experience with requirements engineering, risk management, hazard analysis, traceability, verification & validation, and design controls.
• Ability to translate regulatory concepts into practical, learning-focused content.

Responsibilities

• Design and deliver instructor-led, workshop-based, virtual, and self-paced learning programs for Oracle Health’s regulated product development teams.
• Create onboarding, role-based learning paths, certifications, and continuous education programs.
• Develop scalable learning strategies to improve competency, productivity, compliance, and execution quality.
• Conduct learning needs assessments and partner with leadership to identify capability gaps.
• Collaborate with Engineering, Product Management, Quality, Regulatory Affairs, Clinical Safety, Cybersecurity, TPMs, and Compliance teams.
• Develop content on SaMD, lifecycle processes, risk management, design controls, and regulatory documentation.

Skills

Strong communication & facilitation

Influence technical audiences

Adult learning principles / ID

Project / program management

SaMD / healthcare software knowledge

Education

Bachelor’s degree in Engineering, CS, Healthcare Tech, Regulatory Affairs, Quality, Education, Instructional Design

Job description

Oracle is seeking a Principal Technical Learning Consultant to design, build, and lead learning programs for regulated medical device software. This role focuses on translating regulatory, quality, and systems engineering concepts into practical, role-based experiences for engineers, product managers, TPMs, and quality professionals, supporting Oracle Health’s widespread product development.

You will create onboarding paths, certifications, and continuous education, while shaping learning