Principal SaMD Quality & Compliance Manager – AI Medical Devices

Oracle Health Data Intelligence is hiring a Quality Manager to lead and mature our quality systems and regulatory readiness for AI-enabled Software as a Medical Device (SaMD) and digital health solutions. This role sits within HDI’s Regulatory & Medical Device organization.
You will serve as a hands-on quality leader who ensures HDI maintains world-class quality systems, audit readiness, and regulatory alignment as we scale globally across U.S. and European markets.
This role is ideal for someone who thrives in regulated environments, understands what “good” truly looks like in a quality system, and can operate with both strategic judgment and tactical depth.

At Oracle Health Data Intelligence, our mission is to transform healthcare through trusted, intelligent technology —helping providers, life sciences organizations, and health systems deliver safer care, faster innovation, and better patient outcomes at global scale.
HDI is uniquely positioned at the intersection of:

• Clinical data
• AI and advanced analytics
• Cloud-scale infrastructure
• Regulatory-grade engineering

We are building the next generation of healthcare platforms that don’t just move fast — they move responsibly . Every solution we deliver is designed with:

• Patient safety first
• Scientific rigor
• Regulatory credibility
• Global compliance by design

For professionals in regulatory science and quality , this is a rare opportunity to shape how AI-enabled medical technologies are governed, reviewed, and trusted — not from the sidelines, but from inside one of the world’s most influential healthcare technology organizations.
Your work directly enables:

• Safe adoption of AI/ML in clinical decision-making
• Faster access to life-saving digital health solutions
• Global expansion of compliant, scalable SaMD platforms
• A future where innovation and regulation move together , not in conflict

Quality Systems Leadership

• Own and evolve HDI’s Quality Management System (QMS) aligned with:
  • FDA QSR / 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • IEC 62304
  • SOC2 and InfoSec frameworks

Audit & Inspection Readiness

• Lead preparation for medical device inspections, Notified Body audits, and SOC2/ISO reviews.
• Serve as a primary quality partner during regulatory assessments.

Regulatory & Product Partnership

• Partner with Regulatory Scientists, Engineering, Product, and Security to ensure submissions and technical documentation meet approval standards.

Design Controls & Risk

• Guide implementation of design controls, risk management (FMEA, hazard analysis), V&V, and DHF readiness.

Quality as a Strategic Enabler

• Embed quality early in product development and influence decision-making with strong regulatory judgment.

• 8+ years in medical device, SaMD, or regulated healthcare environments.
• Demonstrated ownership of QMS implementation and audit readiness.
• Strong working knowledge of FDA regulations, ISO 13485, and SOC2 alignment.
• Experience partnering with regulatory affairs and product teams on submissions.
• Ability to operate strategically and tactically.

• Background in digital health, AI/ML medical software, or imaging platforms.
• Experience with CE Mark preparation and Notified Body audits.
• Prior experience at companies such as Enzyme, Cortechs.ai, HealthLytix, Edwards Lifesciences, or ResMed.

Career Level - IC4