Senior Medical Affairs Manager

Owlet Baby Care

Medical Affairs Senior Manager responsible for medical oversight and external communication at Owlet. Leading clinical strategy, supporting safety, and engaging healthcare professionals.

Posted 5/15/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as Owlet's primary internal medical resource and clinical decision-making authority.
Review and interpret adverse event reports, product complaints, and post-market safety signals.
Support development of medical safety narratives for regulatory submissions.
Provide medical review and sign-off on clinical study protocols and informed consent forms.
Advise Owlet's telehealth implementation and digital health initiatives.
Serve as Principal Investigator on Owlet-sponsored clinical investigations.
Maintain current GCP certification and working knowledge of FDA IDE regulations.
Develop and deliver medical and clinical education programs for internal teams.
Provide medical and clinical input into commercial strategy and support the Sales function.
Serve as a credible external clinical voice for Owlet with KOL engagement.
Contribute clinical content to regulatory submissions and filings.

Requirements

What you’ll need

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.
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.
Familiarity with infant monitoring, cardiorespiratory physiology, pulse oximetry, or pediatric sleep medicine is a plus.
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 is nice to have.

Benefits

Comp & perks

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.

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Hard Skills & Tools

clinical decision-makingmedical reviewclinical study protocolsinformed consent formsmedical safety narrativesadverse event reportingpost-market safety signalsclinical education programsKOL engagementregulatory submissions

Soft Skills

communicationleadershipcollaborationadvisory skillsclinical inputstrategic thinkingeducational deliverycredibilityinterpersonal skillspatient care experience

Certifications

MD degreeDO degreeboard certification in PediatricsGCP certificationmedical licensure