Principal Clinical Consultant

Required 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.