Medical Affairs

Owlet Baby Care

13h

About The Position

Owlet is seeking a clinically trained physician to serve as its internal medical authority and primary external clinical voice. The role supports safety, education, and commercial functions and leads medical communications with healthcare providers, advisors, and the broader clinical community. The physician will review safety data, advise on product and regulatory strategy, engage with clinicians and key opinion leaders, and contribute clinical expertise to product and data strategy, including AI-enabled workflows intended to improve infant safety, health, and sleep. The position has broad scope and high autonomy. The role provides medical oversight across product development, safety, regulatory strategy, marketing, and long-term clinical and product strategy. It includes assessing adverse events and post-market safety signals; supporting safety narratives, risk-benefit analyses, and regulatory materials; and reviewing clinical study documents. The physician will serve as Principal Investigator for assigned Owlet-sponsored clinical investigations, with study operations managed by Clinical Operations, and will provide medical direction and review of study data and reports. The position develops internal medical education and reference materials, supports commercial strategy and promotional review, and engages externally with healthcare professionals, KOLs, clinical advisors, conferences, and research collaborators. It also contributes clinical content to regulatory submissions and product documentation; advises Product, Data Science, and Clinical teams on clinical use cases and AI-enabled product and data workflows; and tracks relevant scientific, clinical, healthcare delivery, and competitive developments.

Requirements

MD or DO degree.
Active or inactive medical licensure in the United States.
3–7 years of combined clinical practice and/or industry experience in medical affairs, clinical development, or an MSL role within medical device, digital health, consumer health, or life sciences.
Direct patient care experience.
Strong clinical credibility and communication skills, including the ability to engage physicians, nurses, and other healthcare professionals as a peer.
Ability to translate clinical and scientific complexity into clear, accurate language for non-clinical audiences, including Sales, Marketing, and consumers.
Ability to work across a broad scope in a lean, resource-constrained environment.
Collaborative, adaptable, and mission-driven approach.
For assigned clinical investigations, maintain current GCP certification and working knowledge of FDA IDE regulations (21 CFR Part 812), IRB submission requirements, and informed consent obligations; the posting also states GCP certification may be obtained before study initiation.

Nice To Haves

Board certification in Pediatrics is strongly preferred; candidates in family medicine, neonatology, pulmonology, or other relevant primary care or clinical specialties will be considered.
Familiarity with infant monitoring, cardiorespiratory physiology, pulse oximetry, or pediatric sleep medicine.
GCP certification or willingness to obtain it before clinical study initiation; working knowledge of FDA IDE regulations (21 CFR Part 812) and IRB processes.
Experience in a consumer health or OTC product context.
Prior startup or early-stage company experience.

Responsibilities

Serve as Owlet's primary internal medical resource and clinical decision-making authority, advising on product development, safety, regulatory strategy, marketing, and long-term clinical and product strategy.
Review and interpret adverse event reports, product complaints, and post-market safety signals; provide medical assessments, causality determinations, and clinical recommendations.
Support medical safety narratives for regulatory submissions, PSURs, and post-market surveillance; contribute 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; support identification of external principal investigators when appropriate.
Advise telehealth implementation and digital health initiatives, including parent-facing care experiences, data labeling, feature development, and physician integrations.
Serve as Principal Investigator on assigned Owlet-sponsored clinical investigations, including NSR or IDE studies and PMCF studies, and take accountability for ethical conduct, regulatory compliance, and scientific integrity.
Serve as PI signatory and primary medical contact for IRBs, ethics committees, and regulatory bodies on study conduct, protocol amendments, and safety reporting.
Provide medical direction to Clinical Operations on study design, protocol intent, and clinical judgment; review and interpret interim and final study data and escalate findings appropriately.
Provide medical review and PI sign-off on clinical study reports and collaborate on initiating publication processes after report completion.
Develop and deliver clinical education programs for internal teams, and create and maintain medical reference materials, clinical FAQs, and training content.
Provide medical and clinical input into commercial strategy, product positioning, indication framing, and HCP-facing value propositions.
Serve as medical approval authority for customer-facing promotional materials, digital content, and advertising; participate in MLR review and ensure accuracy and regulatory compliance.
Support Sales with clinical materials, objection-handling content, and medical education resources; participate in customer or payer discussions as needed.
Collaborate with Marketing on evidence-based messaging and consumer scientific communications, ensuring claims meet FDA and FTC standards.
Engage healthcare providers and clinical stakeholders in scientific and medical exchange; build and manage KOL and clinical-advisor relationships and facilitate advisory boards and steering committees.
Represent Owlet at medical conferences, professional society meetings, and educational events through presentations and scientific exchange.
Lead development of HCP-facing medical education materials, clinical evidence summaries, and external white papers in collaboration with the Evidence Strategy & Scientific Communications function.
Support media and public relations activities requiring medical expertise, including consumer health messaging and press inquiries involving medical claims.
Identify external research opportunities, including investigator-initiated studies, academic collaborations, and registry partnerships, and communicate them to the Evidence Strategy & Scientific Communications function.
Contribute clinical content to regulatory submissions and filings, including 510(k), De Novo, or PMA applications; support predicate identification and equivalence analyses with Regulatory Affairs.
Review labeling, instructions for use, and other product documents for clinical accuracy, and align medical affairs priorities with the publication and evidence agenda.
Provide medical input to Product Development during design and post-market phases, including VOC activities, clinical use case definition, and AI-enabled product and data workflows.
Advise on algorithm design input, clinical validation of model outputs, and review of AI-driven features intended to improve infant safety, health, and sleep.
Serve as a clinical thought partner to Data Science and Product teams to ensure models, AI outputs, and features are clinically meaningful, appropriately evidenced, and aligned with pediatric care standards.
Track scientific and clinical developments, healthcare delivery trends, and competitive intelligence relevant to Owlet's products and evidence priorities.

Benefits

Multiple medical plan options, including PPO and High-Deductible plans with HSA.
Dental insurance.
Vision insurance.
Life and disability coverage.
Mental health support and EAP access.
Fitness incentives.
401(k) plan with company match.
Employee stock purchase program and potential equity grants.
Generous flexible PTO policy, including Flex Fridays.
Paid parental leave of up to 14 weeks.
Remote/hybrid work options.