Principal SaMD Learning Architect for Regulated Software

Oracle; United States; On-site; USD 91,400 - 187,000; Full time

Benefits offered by this job

Medical insurance

401(k) Savings with company match

Paid time off

Job summary

Oracle is seeking a Principal Technical Learning Consultant to design and lead learning programs for engineers, product managers, TPMs, and quality professionals across Oracle Health.

You will translate complex regulatory concepts into practical, role-based learning experiences that support more than 10,000 product development professionals. This is a focused, non-traditional training role emphasizing regulatory, quality, and systems engineering learning.

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 working in regulated industries, preferably healthcare, medical device, or Software as a Medical Device (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 lead learning programs for regulated medical device software development.
• Create onboarding, role-based learning paths, workshops, certifications, and ongoing education.
• Develop scalable learning strategies to improve competency, compliance, and execution quality.
• Conduct learning needs assessments and partner with leaders to identify capability gaps.

Skills

Requirements engineering

Risk management

Hazard analysis

Traceability

Verification and validation

Technical documentation

Design controls

Quality systems

Communication

Facilitation

Presentation skills

Education

Bachelor's degree in engineering/CS/healthcare tech/regulatory affairs/education/instructional design

Job description

Oracle is seeking a Principal Technical Learning Consultant to design and lead learning programs for engineers, product managers, TPMs, and quality professionals across Oracle Health.

You will translate complex regulatory concepts into practical, role-based learning experiences that support more than 10,000 product development professionals. This is a focused, non-traditional training role emphasizing regulatory, quality, and systems engineering learning.