Newel Health

Compliance

• 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.

Regulatory Affairs Manager

AI Engineer

• Develop intelligent models that personalize digital therapies.
• Work with real-world data from SaMDs to design machine learning pipelines that predict health risks.
• Build scalable data pipelines for model training, testing, and deployment.
• Work closely with engineering to embed models into production SaMDs.
• Ensure models meet explainability, reproducibility, and regulatory standards.
• Evaluate generative AI tools for education and coaching applications.

Regulatory Affairs Manager

AI/ML Engineer