Director Quality Regulatory Affairs
1 month ago
About Qure.AI:
Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22 million patients in more than 90 countries worldwide. At Qure.ai, we are committed to fostering a diverse and inclusive workplace where talent thrives.
About the Job
Job Title: Director – Quality & Regulatory Affairs
Job Description:
The Director of Quality & Regulatory Affairs will serve as the primary liaison for quality system management and regulatory affairs, interfacing with external (regulatory agencies, customers) and internal stakeholders. This role is ideal for someone with deep knowledge of AI regulations, Software as a Medical Device (SaMD), and global regulatory frameworks, especially FDA, EU MDR, cybersecurity, and quality standards. This individual will lead a team of specialists, coordinate cross-functional deliverables, and guide product approvals and compliance across global markets.
Roles and Responsibilities:
Regulatory Affairs & Compliance Leadership:
- Act as the main regulatory liaison with global regulatory agencies for pre-submissions, submissions, and post-market activities.
- Lead and oversee the development of regulatory pathways, including clinical study design and regulator negotiations.
- Remain current with evolving regulations (FDA, EU MDR, ISO 13485, IEC 62304, ISO 14971) and advise on strategic implications.
Quality Management System (QMS) Oversight:
- Ensure adherence to QMS policies and regulatory standards, including ISO 13485 and FDA guidelines.
- Manage internal and external audits, including preparation, resolution of findings, and coordination with auditing groups.
- Oversee documentation for Corrective and Preventative Actions (CAPA) and ensure it is communicated with all stakeholders.
Cross-functional Collaboration & Strategy:
- Coordinate cross-functional activities to support product development, approval, and strategic planning.
- Partner with internal teams to execute regulatory strategies for global market entry and compliance.
- Act as a regulatory affairs advisor, guiding research directions and influencing strategic decisions.
Product Validation & Compliance:
- Develop and review validation documentation for SaMD and CAD devices to ensure regulatory compliance.
- Review product labeling, marketing materials, and customer statements for compliance and make recommendations.
Regulatory Documentation & Monitoring:
- Assist in the preparation and submission of 510(k) filings.
- Conduct regulatory monitoring activities to identify and respond to new or revised requirements, performing regulatory gap analyses.
What Does Success Look Like:
Success in this role includes ensuring that our products meet or exceed regulatory compliance standards, that cross-functional teams are aligned with regulatory requirements throughout product lifecycles, and that regulatory pathways are efficiently navigated to support timely market entry and sustainable compliance.
Skills and Expertise:
- Proven experience in a senior regulatory role within an AI medical device company.
- Extensive knowledge of FDA and EU MDR requirements, QMS, and medical device regulations.
- Master’s degree (technical discipline preferred); RAC certification is a plus.
- Strategic thinking with the ability to align regulatory needs with portfolio opportunities.
- Strong project management and multitasking skills in cross-functional environments.
- Exceptional written and verbal communication skills for clear documentation, presentations, and team discussions.
- Demonstrated commitment to quality and continuous improvement, with a proactive approach to regulatory challenges.
At Qure.ai:
You will be part of a rapidly growing organization, with an opportunity to work alongside the best minds in the industry. Competitive compensation and rewards, along with the chance to grow with a young company.
Inclusive Workspace:
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Director Quality Regulatory Affairs
1 month ago
India Qure.ai Full timeAbout Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted...
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