Clinical Product Manager Medical Device Safety

Clinical Product Manager (Medical Device Focus)Oracle Health is standing up a specialized clinical product management team focused on medical devicealigned products. This team bridges clinical practice, product strategy, and regulatory engineering to ensure patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, usability, and risk management processes. You'll collaborate across engineering, regulatory, and product leadership teams to align development activities with ISO 14971, IEC 62366, and EU/US Clinical Evaluation standards.Key ResponsibilitiesConduct and contribute to clinical risk analyses (per ISO 14971).Collaborate on Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety.Partner with engineering teams to identify and mitigate clinical risks across design and implementation.Serve as a Clinical and Product-Focused Specialist, providing deep domain expertise in clinical workflows, usability, and patient safety.Provide clinical context for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements.Oversee usability engineering (IEC 62366), ensuring requirements map to user needs and validation meets usability and human factors standards.Lead change management oversight across device-relevant business areas (internal and external), ensuring documentation, communication, and validation of changes.Act as a bridge between Product Management, Clinical Safety, and Health Compliance Organizations (HCOs).Facilitate regulatory awareness and readiness across the broader product organization.Qualifications RequiredLicensed clinician (RN, PharmD, MD, NP, PA, or equivalent) with 5+ years of clinical experience.Minimum 7+ years' experience in product management, clinical informatics, or usability/human factors engineering within healthcare technology or medical devices.Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD).Strong understanding of clinical risk, safety analysis, and usability validation methodologies.Proven ability to translate complex clinical workflows into clear design and engineering requirements.Excellent cross-functional communication and documentation skills.PreferredExperience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.).Experience working with AI-driven medical device applications or software as a medical device (SaMD).Familiarity with Oracle Health/Cerner Millennium or similar EHR platforms.Advanced degree in healthcare informatics, biomedical engineering, or related field.DisclaimerCertain 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: $97,500 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 Oracles 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 opinionShort term disability and long term disabilityLife insurance and AD&DSupplemental life insurance (Employee/Spouse/Child)Health care and dependent care Flexible Spending AccountsPre-tax commuter and parking benefits401(k) Savings and Investment Plan with company matchPaid 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 holidaysPaid 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 leaveAdoption assistanceEmployee Stock Purchase PlanFinancial planning and group legalVoluntary benefits including auto, homeowner and pet insuranceThe 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