医学事务高级经理

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.

#### 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 meetings, and educational events; deliver presentations and participate in scientific exchange activities.
- Lead development of HCP-facing medical education materials, clinical evidence summaries, and external-facing white papers in collaboration with the Evidence Strategy & Scientific Communications function.
- Support media and public relations activities where medical expertise and clinical credibility are required, including consumer health messaging and press inquiries involving medical claims.
- Identify and surface external research opportunities — including investigator-initiated studies, academic collaborations, and registry partnerships — through KOL and advisory relationships and communicate these to the Evidence Strategy & Scientific Communications function to inform the evidence roadmap and integrated publication plan.

#### Regulatory & Cross-functional Support

- Contribute clinical content to regulatory submissions and filings, including 510(k), De Novo, or PMA applications — providing medical narrative, risk-benefit assessment, and clinical interpretation; support predicate identification and equivalence analyses in collaboration with Regulatory Affairs.
- Review labeling, instructions for use (IFU), and other product documents for clinical accuracy; collaborate with the Evidence Strategy & Scientific Communications function to 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 contribution to AI-enabled product and data workflows such as 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, ensuring data models, AI outputs, and product 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 product portfolio and evidence priorities.

#### 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; 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

#### 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 is a plus.
- Experience in consumer health or OTC product context.
- Prior startup or early-stage company experience.

Owlet offers a comprehensive benefits package that supports your health, financial well-being, and work-life balance:

- **Health & Wellness**: Multiple medical plan options (PPO and High-Deductible with HSA), plus dental, vision, life, and disability coverage. Wellness resources include mental health support, EAP access, and fitness incentives.
- **Financial Benefits**: A competitive 401(k) plan with company match, employee stock purchase program, and potential equity grants.
- **Work-Life Balance**: Generous flexible PTO policy, including Flex Fridays, paid parental leave (up to 14 weeks), and remote/hybrid work options.

Owlet Baby Care, Inc. is the equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.