Job Description

Job Description

About hellocare

hellocare is a leader in AI-assisted virtual care delivery, offering an integrated platform that combines advanced software, proprietary hardware, and powerful AI to transform the way healthcare is delivered across hospitals, home care, and primary care settings.

Our comprehensive platform supports Virtual Nursing, Virtual Patient Observation (Sitting), Telehealth, and Patient Engagement—alongside digital whiteboards, room signage, remote patient monitoring (RPM), and AI-powered clinical workflow automation. Our AI-driven fall prevention and detection capabilities are setting new standards for inpatient safety.

Following our recently announced $47 million growth round, backed by leading health systems , hellocare is in hypergrowth mode and scaling rapidly across the U.S. to meet rising demand for smarter, more efficient care delivery models.

We’re on a mission to bridge healthcare and technology to ensure care is accessible, scalable, and efficient—for both providers and patients.

Role Overview: Director of Regulatory Affairs

Join our mission-driven team as the Director of Regulatory Affairs, a senior-level role reporting directly to the executive team. As the Director of Regulatory Affairs, you will lead the company’s efforts in ensuring regulatory compliance, managing Quality Management Systems (QMS), FDA, HITRUST to ensure compliance with US, EU, and global regulatory requirements. Your expertise will play a critical role in aligning hellocare’s innovative solutions with industry standards and regulations, ensuring safe and effective virtual care delivery.

By joining hellocare, you will directly contribute to shaping the future of virtual care by ensuring our products meet the highest standards of quality and compliance. This is your opportunity to make a significant impact on healthcare innovation while ensuring regulatory excellence.

Key Responsibilities:

• Regulatory Compliance: Develop and implement strategies to ensure compliance with FDA, ISO, and other regulatory requirements for medical devices and healthcare technology.
• Quality Management Systems (QMS): Oversee the development, implementation, and maintenance of the company’s QMS, ensuring alignment with regulatory and industry standards.
• Product Certification: Lead efforts for regulatory submissions and approvals, including FDA 510(k) submissions, CE marking, and other certifications required for market entry.
• Risk Management: Develop and maintain risk management processes, ensuring compliance with ISO 14971 and related standards.
• Policy Development: Establish and maintain company policies and procedures to support regulatory and quality initiatives.
• Cross-Functional Collaboration: Work closely with R&D, product, and clinical teams to integrate regulatory requirements into product development and lifecycle management.
• Audits and Inspections: Lead internal and external audits, including FDA and ISO inspections, and ensure readiness for all regulatory reviews.
• Training and Support: Provide training and guidance to internal teams on regulatory and quality requirements.
• Continuous Improvement: Identify opportunities to enhance regulatory and quality processes, driving efficiency and compliance.
• Regulatory Intelligence: Stay current with changes in regulations, standards, and industry trends, ensuring the company remains ahead of compliance requirements.

Your Profile:

• Experience: 8+ years of experience in regulatory affairs and quality management, preferably within the healthcare or medical device industry.
• Expertise: Demonstrated knowledge of FDA regulations, ISO standards, HITRUST and global regulatory requirements for medical devices.
• Leadership: Proven ability to lead regulatory and quality initiatives, including successful FDA submissions and audits.
• Technical Skills: Familiarity with QMS software and tools, as well as regulatory submission platforms.
• Communication: Strong communication and interpersonal skills, with the ability to engage cross-functional teams and external stakeholders.
• Problem-Solving: Skilled in identifying and addressing regulatory and quality challenges proactively.
• Education: Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
• Certifications: RAC (Regulatory Affairs Certification) or similar credentials are a plus.

Why Join hellocare.ai?

• Be part of a company that is leading the transformation of virtual care delivery, partnering with the top health systems across the country.
• Opportunities for professional growth in high-growth environment with cutting-edge technology that is directly solving critical healthcare challenges like nurse shortages and clinician burnout.
• Competitive salary with performance-based incentives.
• Comprehensive health insurance and benefits.
• A dynamic, supportive team culture that fosters innovation and impact.
• Make a real difference in the future of healthcare delivery in a fast-paced, innovative environment.

If you're passionate about transforming healthcare through innovation and want to be part of a mission-driven team, we’d love to hear from you. Apply today and join us in shaping the future of virtual care delivery.

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