Senior Patient Safety Strategist

** Job Description*
* The Patient Safety Strategist provides independent clinical safety assessments for complaints involving regulated health software, medical-device functionality, and clinically significant customer-reported events. The role evaluates potential patient and end-user impact, documents evidence-based clinical assessments, supports Clinical Impact Assessments, Health Hazard Evaluations, and collaborates with Quality, Regulatory Affairs, Product, Engineering, and Customer Support.

** Required qualifications*
* + Bachelor's degree or higher in Nursing, Medicine, Clinical or Medical Laboratory Science, Pharmacy, Allied Health, or a related clinical discipline.

+ Current, active clinical licensure or relevant professional certification in an applicable clinical discipline.

+ Six or more years of direct clinical practice, clinical informatics, patient safety, health technology, or regulated healthcare-product experience.

+ Ability to assess patient-safety implications of EHR workflows, clinical decision support, medication management, orders and results, interoperability, identity, alerts, and other health-IT functionality.

+ Strong written clinical reasoning skills, including the ability to distinguish documented facts, reasonable clinical inferences, uncertainty, and information gaps.

+ Ability to manage a high-volume case queue while recognizing and escalating urgent or potentially serious cases.

+ Experience collaborating with nonclinical partners, including Product Management, Engineering, Quality, Regulatory Affairs, and Customer Support.

+ Strong judgment, organization, and communication skills.

** Preferred qualifications*
* + Experience in medical device, SaMD, EHR, clinical informatics, post-market surveillance, complaint handling, Quality, Regulatory Affairs, or patient-safety functions.

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Experience with Clinical Impact Assessments, Health Hazard Evaluations, benefit-risk assessment, CAPA, complaint investigations, or vigilance.

+ Experience in acute care, medication management, laboratory, diagnostic, interoperability, or high-acuity clinical workflows.

+ Working knowledge of medical-device or SaMD risk management and post-market requirements.

+ Experience reviewing AI-generated documentation in a regulated environment.

** Responsibilities*
* ** Key Responsibilities*
* + Conduct timely, evidence-based clinical reviews of customer complaints involving regulated and non-regulated healthcare software, including Software as a Medical Device (SaMD).

+ Assess reported or potential patient and end-user harm and determine whether available information indicates a clinically significant safety concern, potential product-related deficiency, or need for further clinical evaluation.

+ Document concise, defensible clinical rationale using approved complaint-handling and clinical-review frameworks.

+ Lead or support Clinical Impact Assessments and provide clinical input to Health Hazard Evaluations, vigilance activities, benefit-risk assessments, field-action assessments, and other assigned post-market safety activities.

+ Identify missing clinical or functional information and coordinate focused evidence requests with Product, Engineering, Quality, and other subject-matter experts.

+ Participate in cross-functional complaint reviews while maintaining an independent clinical-safety perspective.

+ Identify potential safety signals and recurring complaint patterns, escalating significant trends through established governance channels.

+ Support continuous improvement of clinical-review templates, decision support, training, and approved AI-enabled tools.

+ Meet global complaint-handling timelines and escalate risks that may affect timely assessment or reporting.

** Success in the role*
* A successful…