Senior SaMD Learning Architect – Regulated Product Development

Ll Oefentherapie; United States; On-site; USD 91,000 - 187,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Paid time off and flexible vacation

401(k) Savings and Investment Plan

Adoption assistance

Job summary

Oracle is seeking a Principal Technical Learning Consultant to design and lead learning programs for SaMD product development and QA. You will translate regulatory, quality, and systems engineering concepts into practical, role‑based training for engineers and leaders across Oracle Health.

You’ll collaborate with Engineering, Regulatory Affairs, Quality, and TPMs to build scalable content, ensure audit readiness, and support AI governance and modern cloud‑native software development environments.

Qualifications

• 8+ years of experience in medical device software, healthcare technology, quality engineering, systems engineering, regulatory affairs, product development, technical program management, or technical learning.
• Experience in regulated industries, preferably healthcare or SaMD environments.
• Strong understanding of software development lifecycle processes.
• Direct experience with requirements engineering, risk management, hazard analysis, traceability, verification and validation, technical documentation, design controls, quality systems.

Responsibilities

• Design and deliver instructor‑led, workshop‑based, virtual, and self‑paced learning programs.
• Create onboarding, role‑based learning paths, technical workshops, certifications, and continuous education programs.
• Develop scalable learning strategies to improve competency, productivity, compliance, and execution quality.
• Collaborate with leadership to identify capability gaps and organizational priorities.
• Develop learning content for SaMD and regulatory excellence across product development teams.
• Measure learning effectiveness and continuously improve content based on feedback and audits.

Skills

Communication skills

Facilitation

Presentation skills

Influencing technical audiences

English proficiency

Education

Bachelor's degree in Engineering/CS/Healthcare Technology/Regulatory Affairs/Quality/Education/Instructional Design

Job description

Oracle is seeking a Principal Technical Learning Consultant to design and lead learning programs for SaMD product development and QA. You will translate regulatory, quality, and systems engineering concepts into practical, role‑based training for engineers and leaders across Oracle Health.

You’ll collaborate with Engineering, Regulatory Affairs, Quality, and TPMs to build scalable content, ensure audit readiness, and support AI governance and modern cloud‑native software development environments.