Senior Medical Affairs Manager

🕒 il y a 26 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👔 Manager

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Owlet Baby Care

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2013

⚕️ Assurance santé

🧘 Bien-être

🛍️ eCommerce

Healthcare Insurance • Wellness • eCommerce

Owlet Baby Care est une entreprise pionnière spécialisée dans les solutions innovantes de surveillance de la santé pour les nourrissons. Leurs produits, comprenant la chaussette Dream Sock approuvée par la FDA et le Dream Duo, combinent une technologie avancée pour fournir des lectures de santé en temps réel telles que le rythme cardiaque et le niveau d'oxygène, permettant aux parents de surveiller le bien-être de leurs bébés dans le confort de leur domicile. L'entreprise vise à réduire l'anxiété parentale en offrant des outils qui améliorent la qualité du sommeil et la tranquillité d'esprit des familles.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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.