Regulatory Affairs Director for AI Medical Devices

1 month ago

Thoothukudi, Tamil Nadu, India Qure Full time

About Qure.AI:

We are the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. Our cutting-edge solutions significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Over 22 million patients in more than 90 countries worldwide have benefited from our innovative technologies.

About the Job

Job Title: Regulatory Affairs Director – Quality & Compliance

Job Description:

The Regulatory Affairs Director 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.

Responsibilities:

  • 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.

Estimated Salary: $150,000 - $200,000 per year, depending on experience and qualifications.

Benefits: Competitive compensation package, inclusive workspace, and opportunities for growth and professional development.

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