Medical Affairs Sr. Manager

Owlet is seeking a clinically trained Medical Affairs Manager to serve as the company's internal medical authority and primary external clinical voice. This individual will support the safety, education, and commercial functions of the business from a medical perspective, while leading external medical communications with healthcare providers, advisors, and the broader clinical community. The role is designed for a physician who is equally comfortable reviewing safety data, advising on product and regulatory strategy, and engaging confidently with clinicians and KOLs. This physician will also contribute clinical expertise to Owlet's product and data strategy — including AI-enabled workflows designed to improve infant safety, health, and sleep — ensuring that technology development is grounded in clinical evidence and real-world pediatric practice. This person will operate with broad scope and high autonomy.

Core Competencies

• Strong clinical credibility and communication skills — able to engage confidently with physicians, nurses, and other HCPs as a peer.
• Ability to translate clinical and scientific complexity into clear, accurate language for non-clinical audiences including Sales, Marketing, and consumers.
• Comfortable operating across a broad scope in a lean, resource-constrained environment.
• Collaborative, adaptable, and mission-driven — energized by the opportunity to improve outcomes for families and children.

Requirements

Internal Medical Authority & Safety Support

• Serve as Owlet's primary internal medical resource and clinical decision-making authority — advising across product development, safety, regulatory strategy, marketing, and long-term clinical and product strategy in collaboration with senior leadership.
• 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; contribute clinical expertise to risk-benefit analyses and failure mode assessments.
• Provide medical review and sign-off on clinical study protocols, informed consent forms, and clinical investigation plans prepared by Clinical Operations; support identification of external principal investigators where internal PI designation is not appropriate.
• Advise Owlet's telehealth implementation and digital health initiatives — contributing clinical perspective to parent-facing care experiences, data labeling, feature development, and physician integrations intended to improve infant safety, health, and sleep.

Clinical Study Leadership & Principal Investigator

• 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 of assigned studies. Operational execution of all study phases is managed by Clinical Operations.
• Maintain current GCP certification and working knowledge of FDA IDE regulations (21 CFR Part 812), IRB submission requirements, and informed consent obligations; serve as PI signatory and primary medical point of contact for IRBs, ethics committees, and regulatory bodies on all matters related to study conduct, protocol amendments, and safety reporting obligations.
• Provide medical direction to Clinical Operations on study design, protocol intent, and clinical judgment throughout study conduct; review and interpret interim and final study data, providing medical assessment of safety signals and adverse events and escalating findings appropriately to Regulatory Affairs and Quality.
• Provide medical review and PI sign-off on clinical study reports (CSRs) prepared by Clinical Operations; collaborate with the Evidence Strategy & Scientific Communications function to initiate the publication process upon CSR completion.

Medical Education — Internal

• Develop and deliver medical and clinical education programs for internal teams — including Sales, Marketing, Customer Experience, and Product Development — to build organizational understanding of relevant clinical topics, disease states, and patient populations.
• Serve as an internal educator on pediatric health, infant monitoring, respiratory and cardiac physiology, and the clinical context in which Owlet's products are used.
• Create and maintain internal medical reference materials, clinical FAQs, and training content to support accurate and compliant communication across teams.

Commercial Support

• Provide medical and clinical input into commercial strate