Senior Medical Affairs Manager

🕒 Maio 15

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Owlet Baby Care

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2013

⚕️ Seguro de Saúde

🧘 Bem-estar

🛍️ Comércio Eletrônico

Healthcare Insurance • Wellness • eCommerce

A Owlet Baby Care é uma empresa pioneira que se especializa em soluções inovadoras de monitoramento de saúde para bebês. Seus produtos, incluindo a Meia dos Sonhos autorizada pela FDA e o Dream Duo, combinam tecnologia avançada para fornecer leituras de saúde em tempo real, como frequência cardíaca e níveis de oxigênio, permitindo que os pais monitorem o bem-estar de seus bebês no conforto de casa. A empresa visa reduzir a ansiedade dos pais oferecendo ferramentas que melhoram a qualidade do sono e trazem tranquilidade para as famílias.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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.