Senior Staff Clinical Consultant
OracleRequired Qualifications:
Licensed clinician (RN, PharmD, MD, NP, PA, or equivalent) with 10+ years of clinical experience.
· Minimum 10+ 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.
Responsibilities
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.
· Partner closely with Medical Device Tiger Teams and transition into broader next-generation device initiatives.
Qualifications
Career Level - IC4