Newel Health
51 - 200 employees
Founded 2022
💊 Pharmaceuticals
🤖 Artificial Intelligence
🤝 B2B
💰 $2.5M Grant - Newel Health on 2023-02
Pharmaceuticals • Artificial Intelligence • B2B
Newel Health is an AI-driven digital health company that develops regulatory-grade digital medical devices and software-as-a-medical-device (SaMD) in partnership with pharmaceutical and medtech companies. It co-develops evidence-based therapeutics, digital biomarkers, endpoints, and companion apps across cardiometabolic disease, neurological conditions (including Parkinson’s), and chronic pain, and acts as a legal manufacturer responsible for regulatory compliance (ISO 13485, MDR, FDA-aligned). Its H. Core platform integrates AI, behavioral science, and real-world data to build, scale, and deploy clinical-grade digital therapeutics and remote monitoring solutions for healthcare systems and pharma partners.
Quality System Manager
Job not on LinkedIn
🕒 March 20
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Newel Health
51 - 200 employees
Founded 2022
💊 Pharmaceuticals
🤖 Artificial Intelligence
🤝 B2B
💰 $2.5M Grant - Newel Health on 2023-02
Pharmaceuticals • Artificial Intelligence • B2B
Newel Health is an AI-driven digital health company that develops regulatory-grade digital medical devices and software-as-a-medical-device (SaMD) in partnership with pharmaceutical and medtech companies. It co-develops evidence-based therapeutics, digital biomarkers, endpoints, and companion apps across cardiometabolic disease, neurological conditions (including Parkinson’s), and chronic pain, and acts as a legal manufacturer responsible for regulatory compliance (ISO 13485, MDR, FDA-aligned). Its H. Core platform integrates AI, behavioral science, and real-world data to build, scale, and deploy clinical-grade digital therapeutics and remote monitoring solutions for healthcare systems and pharma partners.
📋 Description
• Maintain and improve our QMS in alignment with ISO 13485, MDR, and applicable FDA regulations. • Support internal and supplier audits, prepare documentation, and lead follow-up activities. • Manage CAPAs, nonconformities, and change control documentation. • Provide QA oversight to product development activities, including design controls and verification/validation protocols. • Train internal teams on quality procedures and support audit readiness across functions.
🎯 Requirements
• 3+ years of quality assurance experience in medical devices or health tech. • Solid understanding of ISO 13485, ISO 14971, IEC 62304, IEC 62366 and MDR compliance. • Strong documentation and organizational skills. • Excellent English communication skills.
🏖️ Benefits
• Remote-first culture • Collaboration with cross-disciplinary teams
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