Principal SaMD Quality & Compliance Manager - AI Medical Devices

Job Description

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

Responsibilities

Key Responsibilities

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.

Required Qualifications

• 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.

Preferred Experience

• 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

Disclaimer:

Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.

Range and benefit information provided in this posting are specific to the stated locations only

US: Hiring Range in USD from: $90,100 to $199,500 per annum. May be eligible for bonus and equity.

Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.

Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.

Oracle US offers a comprehensive benefits package which includes the following:

Medical, dental, and vision insurance, including expert medical opinion

Short term disability and long term disability

Life insurance and AD&D

Supplemental life insurance (Employee/Spouse/Child)

Health care and dependent care Flexible Spending Accounts

Pre-tax commuter and parking benefits

401(k) Savings and Investment Plan with company match

Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.

11 paid holidays

Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.

Paid parental leave

Adoption assistance

Employee Stock Purchase Plan

Financial planning and group legal

Voluntary benefits including auto, homeowner and pet insurance

The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.

Career Level - IC4

About Us

As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.

We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.

Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.

We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing [email protected] or by calling +1 888 404 2494 in the United States.

Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.