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Owlet Baby Care is seeking a clinically trained Medical Affairs Physician to serve as the company's internal medical authority and primary external clinical voice. This role bridges safety, regulatory, product development, and commercial functions from a clinical perspective.
Key Responsibilities:
Internal Medical Authority & Safety: Serve as Owlet's primary internal medical resource and clinical decision-making authority across product development, safety, regulatory strategy, and long-term clinical strategy. Review and interpret adverse event reports, product complaints, and post-market safety signals; provide medical assessment, causality determination, and clinical recommendations to Quality, Regulatory, and Clinical Operations teams. Support development of medical safety narratives for regulatory submissions, PSURs, and post-market surveillance activities. Provide medical review and sign-off on clinical study protocols, informed consent forms, and clinical investigation plans.
Clinical Study Leadership: Serve as Principal Investigator (PI) on Owlet-sponsored clinical investigations, including NSR or IDE studies and post-market clinical follow-up (PMCF) studies, taking personal accountability for ethical conduct, regulatory compliance, and scientific integrity. Maintain current GCP certification and working knowledge of FDA IDE regulations (21 CFR Part 812) and IRB submission requirements. Provide medical direction to Clinical Operations on study design and protocol intent; review and interpret interim and final study data.
Medical Education: Develop and deliver medical and clinical education programs for internal teams (Sales, Marketing, Customer Experience, Product Development) to build organizational understanding of relevant clinical topics and disease states. Create and maintain internal medical reference materials, clinical FAQs, and training content.
Commercial Support: Provide medical and clinical input into commercial strategy, including product positioning and indication framing. Serve as medical approval authority for all customer-facing promotional materials, digital content, and advertising; participate in medical-legal-regulatory (MLR) review. Support Sales with clinical materials and HCP objection-handling content. Collaborate with Marketing on evidence-based messaging frameworks for OTC/wellness products.
External Medical Communications & KOL Engagement: Serve as a credible external clinical voice for Owlet, engaging healthcare providers, pediatricians, neonatologists, and other clinical stakeholders. Build and manage relationships with key opinion leaders and clinical advisors; plan and facilitate advisory board meetings. Represent Owlet at medical conferences and professional society meetings. Lead development of HCP-facing medical education materials and clinical evidence summaries. Support media and public relations activities involving medical expertise.
Regulatory & Cross-functional Support: Contribute clinical content to regulatory submissions (510(k), De Novo, PMA applications). Review labeling and instructions for use for clinical accuracy. Provide medical input to Product Development during design and post-market phases. Serve as a clinical thought partner to Data Science and Product teams on AI-enabled workflows designed to improve infant safety, health, and sleep. Track scientific and clinical developments relevant to Owlet's product portfolio.
Core Competencies Required: Strong clinical credibility and communication skills; ability to translate clinical and scientific complexity into clear language for non-clinical audiences; comfortable operating across broad scope in a lean environment; collaborative, adaptable, and mission-driven.
Qualifications:
Education & Licensure: MD or DO degree required; board certification in Pediatrics strongly preferred. Other primary care or relevant clinical specialties will be considered (family medicine, neonatology, pulmonology). Active or inactive medical licensure in the United States required; industry-based role does not require active clinical practice.
Experience: 3–7 years of combined clinical practice and/or industry experience in medical affairs, clinical development, or a medical science liaison (MSL) role within medical device, digital health, consumer health, or life sciences. Direct patient care experience required.
Nice to Have: Familiarity with infant monitoring, cardiorespiratory physiology, pulse oximetry, or pediatric sleep medicine. GCP certification or willingness to obtain prior to clinical study initiation; working knowledge of FDA IDE regulations (21 CFR Part 812) and IRB processes. Experience in consumer health or OTC product context. Prior startup or early-stage company experience.
