Medical Affairs Sr. Manager
Owlet Baby Care · United States · 2 wk ago
RemoteRemoteHealthcarePart-time
About the role
Owlet is seeking a clinically trained Medical Affairs Manager to serve as the company's internal medical authority and primary external clinical voice.
Responsibilities
- 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.
- Operate with broad scope and high autonomy.
Requirements
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