Oracle

Oracle Health is standing up a specialized clinical product management team focused on medical device–aligned 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 Responsibilities

· Conduct 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

Required:

· Licensed 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.

Preferred:

· Experience 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.

IC4 - Career Level