Regulatory Affairs Manager

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Newel Health

WebsiteLinkedInAll Job Openings

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

• Own the preparation and submission of technical documentation for MDR compliance, including GSPR checklists, clinical evaluation reports, and risk assessments. • Maintain product registration portfolios across EU and international markets, collaborating with notified bodies and competent authorities. • Interpret and communicate regulatory requirements to internal teams and advise on labeling, software changes, and product updates. • Partner with quality, engineering, and clinical teams to ensure regulatory requirements are implemented throughout development. • Monitor evolving global regulations for digital health and provide strategic guidance to ensure long-term compliance. • Establish and oversee post-market surveillance activities, including complaint handling, vigilance reporting, and trend analysis, to ensure ongoing product safety and compliance.

🎯 Requirements

• 4+ years in regulatory affairs for medical devices or digital health, with direct experience in EU MDR and US FDA. • Strong understanding of SaMD, ISO 13485, IEC 62304, IEC 62366 and risk management under ISO 14971. • Experience leading CE mark submissions, FDA clearance and interacting with notified bodies. • Fluent in English; additional EU languages a plus.

🏖️ Benefits

• Flexible work arrangements • Professional development