Associate Medical Director, Medical Affairs
Core
Provide medical, scientific, and clinical expertise to support the development, regulatory approval, commercialization, and post-market performance of diagnostic products, serving as a key medical resource for product development teams.
Role type
Associate Medical Director (Medical Affairs)
Builds
Diagnostic solutions for hospitals, laboratories, and clinics
Domain
Healthcare / Medical Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical judgment, product development knowledge, risk management, regulatory requirements understanding, clinical study support, safety signal assessment, medical oversight, benefit-risk analysis, regulatory agency interaction, clinical data review
Preferred skills
Laboratory settings experience, NP/MD/DO clinical experience
Technologies
Medical Device Reporting (MDR), Health Hazard Evaluations (HHEs), FDA regulations
Responsibilities
Evaluate clinical and product performance data to translate findings into actionable recommendations; Assess safety risks and clinical benefit-risk profiles throughout the product lifecycle; Partner with Medical Directors to develop medical assessment documents and clinical evidence summaries; Provide guidance on laboratory medicine, diagnostic testing practices, and healthcare workflows; Support design control activities by ensuring clinical requirements are incorporated into product design; Review and assess product complaints, adverse event trends, and post-market data to identify safety concerns; Conduct or support Health Hazard Evaluations and medical risk assessments; Present medical assessments and scientific recommendations to leadership and stakeholders; Represent Medical Affairs at scientific meetings and physician engagements.
Seniority
Mid-Senior, hands-on IC
