Medical Affairs Sr. Manager

About this role

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 strategy, including product positioning, indication framing, and HCP-facing value propositions for both the prescription device and OTC/wellness product.
Serve as medical approval authority for all customer-facing promotional materials, digital content, and advertising — participating in medical-legal-regulatory (MLR) review and ensuring scientific accuracy and regulatory compliance across all channels.
Support the Sales function with clinical materials, HCP objection-handling content, and medical education resources; participate in key customer or payer discussions as the medical representative when needed.
Collaborate with Marketing on evidence-based messaging frameworks and consumer scientific communications for the OTC/wellness product, ensuring claims are defensible under FDA and FTC standards.
External Medical Communications & KOL Engagement
Serve as a credible external clinical voice for Owlet — engaging healthcare providers, pediatricians, neonatologists, and other clinical stakeholders in scientific and medical exchange.
Build and manage relationships with key opinion leaders, clinical advisors; plan and facilitate advisory board meetings and steering committees.
Represent Owlet at medical conferences, professional society…