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Newelhealth
The Regulatory Affairs Portfolio Manager is responsible for defining and maintaining the regulatory strategy and technical file for Newel's medical device software, ensuring compliance from classification through submission and post-market maintenance. This role serves as the primary regulatory partner to internal teams, notified bodies, and authorities, overseeing risk management, audits, and stakeholder relationships. The position requires expertise in EU MDR and FDA SaMD regulations to support product development and lifecycle management.
Newel Health is an ISO 13485-certified legal manufacturer of AI-driven Software as Medical Devices (SaMDs) for chronic disease management. The company develops and deploys CE MDR-certified digital medical devices — including Amicomed for hypertension and Rohkea™ for chronic musculoskeletal pain — combining AI, behavioural science, and real-world data across cardiometabolic, neurology, and pain therapeutic areas. Newel Health also partners with pharmaceutical companies and healthcare systems to co-develop certified SaMDs, digital endpoints, and companion therapeutics.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for Newelhealth.
Newelhealth didn’t post a salary, so this is our estimate from similar listings.
18% below the average for this role
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