As an individual contributor at Oracle Health, you will play a pivotal role in modernizing clinical risk management and regulatory practices by providing strategic oversight across product development teams to ensure compliance with FDA, MDR, and ISO 14155 standards. Your day-to-day responsibilities include collaborating with cross-functional teams to integrate clinical context, manage patient safety risks, and maintain robust compliance throughout the software and medical device lifecycle. Ideal candidates have a medical degree and extensive experience in clinical leadership roles within regulated healthcare sectors, along with expertise in FDA, MDR, and ISO 14155 compliance and AI-driven process improvements. This role requires knowledge of software development processes, including agile methodologies, and strong collaboration skills to train and mentor diverse technical and clinical teams.
Skills
FDA
MDR
ISO 14155
Agile
AI-enabled methodologies
Clinical risk management
Product hazard assessment
Safety evaluation
Regulatory submission process
Cross-functional team leadership
Training and mentorship
External audit experience
Post-market surveillance
Risk management plans
AFMEAs
Health Product Hazard Assessments
Field Safety Corrective Actions
Device adverse events
Malfunction coding
What you'll do
Provide strategic clinical oversight across Oracle Health to align with FDA, MDR, and ISO 14155 standards.
Ensure robust compliance and risk management for software and medical devices throughout their lifecycle.
Oversee the generation and dissemination of clinical evidence and patient safety data for publications.
Assess product complaints requiring medical interpretation and ensure accurate reporting to regulatory authorities.
Develop and review risk management plans, including Health Product Hazard Assessments and Field Safety Corrective Actions.
What we're looking for
Medical degree (MD, DO, or equivalent) required; board certification preferred.
At least 7 years of clinical leadership experience in medical device or digital health sectors.
Extensive knowledge of FDA, MDR, and ISO 14155 compliance standards.
Proven ability to lead cross-functional teams and serve as a principal authority on clinical and regulatory matters.
Experience with product hazard assessment and safety evaluation processes.
Strong collaboration and communication skills for training and mentoring diverse technical and clinical teams.
Direct experience working with regulatory authorities and notified bodies.
Market check
Salary context
This
$97,500–$199,500
range sits above
30%
of similar postings on FindRole.
Peer median band
$128,800–$208,800
Median floor and ceiling across peers.
Typical midpoint (25–75%)
$142,200–$213,481
Middle half of comparable postings.
Based on 240 comparable postings.*
* 240 is the maximum number of comparable postings sampled.
Employer
About Oracle
Oracle Corporation is a leading multinational technology company specializing in database software, cloud computing, and enterprise software.
Oracle currently has
251 open roles
on FindRole.
Listed pay typically runs
$97,500–$199,500
across 193 roles with salary data.