Head of Quality Assurance & Regulatory Affairs (QA/RA)

DESKi And HeartFocus Description

DESKi has built HeartFocus, a revolutionary, AI-driven heart exam software that empowers any healthcare professional to perform world-class echos from any device, anywhere. Driven by the belief No heart can wait ™, HeartFocus provides a life-saving solution for heart patients, facilitating early detection and disease prevention. After 4 years of research and having secured its financing, DESKi will start commercialization in 2025, FDA and CE applications are pending. We are seeking a dynamic and experienced Head of QA/RA to drive the regulatory approval and quality management of our AI-driven software.

Mission

Regulatory Affairs (RA):

• Develop and execute regulatory strategies to achieve and maintain FDA approval, CE marking, and other necessary global certifications
• Primary liaison with regulatory authorities (e.g., FDA, Notified Bodies, EMA) and manage regulatory submissions and pre-submissions, renewals, and compliance reports.
• Monitor and interpret changes in regulatory requirements, ensuring the company’s processes and products remain compliant.
• Provide guidance and training to internal teams on regulatory requirements and standards for SaMD, including MDR, and FDA regulations.

Quality assurance:

• Maintain and improve our quality management system (QMS) to be compliant with ISO 13485 and other relevant standards. (certification ISO 13485 already obtained on an eQMS with Jira/Confluence)
• Manage internal and external audits, ensuring adherence to regulatory requirements and continuous quality improvement.
• Manage risk assessments and ensure effective risk management processes
• Manage QA/RA intern

Leadership & Collaboration:

• Train the DESKi team, fostering a culture of quality and regulatory excellence.
• Collaborate with R&D, product, clinical, and marketing teams to ensure regulatory requirements are met
• Represent the QA/RA function in executive discussions and strategic planning.
• Direct reporting to the CEO

Experience and Qualifications

• Minimum 5 years of experience in Quality Assurance and Regulatory Affairs
• Experience in obtaining FDA clearance, or/and CE marking for Software as a Medical Device (SaMD)
• Experience in the regulatory pathway for software and AI algorithm
• In-depth knowledge of relevant standards such as ISO 13485 (medical devices), IEC 62304, ISO 14971, and Good Manufacturing Practices (GMP).
• Basic understanding of software and algorithm development

What we propose

• Human adventure to build a smarter path to heart exam for all
• Salary: 60-75k€ depending on experience

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