Principal SaMD Learning Architect — Regulated Product Dev

Oracle; Raleigh (NC); On-site; USD 91,000 - 187,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid time off

Paid parental leave

Job summary

Oracle Health seeks a Principal Technical Learning Consultant to design, build, and lead learning programs for regulated medical device software development. This role translates complex regulatory concepts into practical, role‑based experiences for engineers, product managers, TPMs, and quality professionals.

The candidate will shape an embedded learning function serving thousands of product development professionals, collaborating with Engineering, Regulatory, Quality, and Compliance teams to

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Healthcare Technology, Regulatory Affairs, Quality, Education, Instructional Design, or related field.
• 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, medical device, or SaMD environments.
• Strong understanding of software development lifecycle processes.
• Direct experience with requirements engineering.
• Direct experience with risk management.
• Direct experience with hazard analysis.
• Direct experience with traceability.
• Direct experience with verification and validation.
• Direct experience with technical documentation.
• Direct experience with design controls.
• Direct experience with quality systems.
• Exceptional communication, facilitation, and presentation skills.
• Ability to influence highly technical audiences across multiple organizations.

Responsibilities

• Design and deliver instructor‑led, workshop‑based, virtual, and self‑paced learning programs supporting Oracle Health’s regulated product development organizations.
• Create onboarding, role‑based learning paths, technical workshops, certifications, and continuous education programs.
• Develop scalable learning strategies that improve competency, productivity, compliance, and execution quality.
• Conduct learning needs assessments and partner with leadership to identify capability gaps and organizational priorities.
• Partner with subject matter experts to transform complex technical knowledge into practical learning experiences.
• Develop content that enables teams to perform regulated development activities within Oracle’s Quality Management System.

Job description

Oracle Health seeks a Principal Technical Learning Consultant to design, build, and lead learning programs for regulated medical device software development. This role translates complex regulatory concepts into practical, role‑based experiences for engineers, product managers, TPMs, and quality professionals.

The candidate will shape an embedded learning function serving thousands of product development professionals, collaborating with Engineering, Regulatory, Quality, and Compliance teams to