Head of Clinical Affairs - US & EU (Remote)

OneRagtime; Boston (MA); Híbrido; USD 180 000 - 200 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health Insurance (Medical plan, vision

401(k)

Life Insurance

Parental Policy

PTO

Offices in Boston & New York

Flexible hours & remote policies

Commuter Benefits

Offsite in France & team events

Coaching & development

Resumo da oferta

Sonio is a mission-driven medical AI company seeking its first US Clinical Affairs hire, reporting to the CEO and sitting on the Excom. You will own the clinical strategy end-to-end and translate executive priorities into a studies roadmap with RAQA, DS, and Marketing teams.

Based in Boston with remote flexibility, you will build a 3-person team, manage the clinical budget, and drive global KOL engagement, while ensuring regulatory submissions and high standards of clinical practice.

Qualificações

• 12+ years in Clinical Affairs at a medical-device firm.
• Experience with AI / SaMD and healthtech scale-ups.
• Strong background in MFM / OBGYN / prenatal medicine.
• Knowledge of validation, post-market, and real-world evidence.
• Proven collaboration with RAQA on FDA 510(k) and EU MDR.

Responsabilidades

• Own clinical strategy end-to-end and roadmap with CSO.
• Manage a 3-person clinical team and budget.
• Lead FDA 510(k) and EU MDR submissions with RAQA.
• Drive KOL engagement and medical knowledge diffusion.
• Build scalable, repeatable clinical operations worldwide.

Conhecimentos

Clinical Affairs

AI SaMD

Healthcare

Clinical study design

RAQA liaison

Team leadership

Descrição da oferta de emprego

Sonio is a mission-driven medical AI company seeking its first US Clinical Affairs hire, reporting to the CEO and sitting on the Excom. You will own the clinical strategy end-to-end and translate executive priorities into a studies roadmap with RAQA, DS, and Marketing teams.

Based in Boston with remote flexibility, you will build a 3-person team, manage the clinical budget, and drive global KOL engagement, while ensuring regulatory submissions and high standards of clinical practice.