Director Quality & Regulatory Affairs Job in Qure.ai

Director Quality & Regulatory Affairs

Location: Mumbai, India

Employment Type: Full-time

Job Description

We are seeking an experienced Director of Quality & Regulatory Affairs to lead our regulatory and quality initiatives at the company. This critical leadership role will involve direct oversight of regulatory submissions, quality management systems, and cross-functional collaboration to ensure compliance with global standards. As the regulatory affairs expert, you will navigate complex regulatory pathways, oversee quality systems, and ensure compliance with evolving standards to drive global market entry and product success.

Roles & Responsibilities

Regulatory Affairs & Compliance Leadership

• Serve as the primary point of contact for regulatory agencies globally, managing pre-submissions, submissions, and post-market regulatory activities.
• Lead the development of regulatory pathways, clinical study designs, and regulatory negotiations, ensuring alignment with regulatory requirements.
• Stay up-to-date with evolving regulations (e.g., EU MDR, ISO 13485, IEC 62304, ISO 14971) and advise on strategic regulatory implications.

Quality Management System (QMS) Oversight

• Ensure the organization s adherence to QMS policies and regulatory standards such as ISO 13485 and FDA guidelines.
• Oversee internal and external audits, including preparation, issue resolution, and coordination with external auditing bodies.
• Manage documentation for Corrective and Preventative Actions (CAPA), ensuring effective communication and resolution with all stakeholders.

Cross-functional Collaboration & Strategy

• Collaborate with various internal teams to develop regulatory strategies for product development, market approval, and strategic planning.
• Advise teams on regulatory affairs, guiding research directions and influencing strategic product decisions to align with global regulatory requirements.

Product Validation & Compliance

• Develop and review validation documentation for Software as a Medical Device (SaMD) and Computer-Aided Design (CAD) devices to ensure regulatory compliance.
• Review product labeling, marketing materials, and customer-facing statements for regulatory compliance, offering guidance and recommendations where necessary.

Regulatory Documentation & Monitoring

• Lead the preparation and submission of EU MDR filings, ensuring timely and complete documentation.
• Monitor ongoing regulatory developments and perform regulatory gap analyses to identify and respond to new or revised regulatory requirements.

What Does Success Look Like?

Success in this role is defined by ensuring our products consistently meet or exceed global regulatory compliance standards, aligning cross-functional teams with regulatory requirements throughout product lifecycles, and effectively navigating regulatory pathways to support timely market entry and ongoing compliance.

Requirements

• Proven experience in a senior regulatory role within an AI medical device company.
• Extensive knowledge of EU MDR, QMS, and medical device regulations.
• Master s degree in a technical discipline (preferred), RAC certification is a plus.
• Strategic thinking with the ability to align regulatory requirements with portfolio opportunities and company goals.
• Strong project management skills, with the ability to multitask and manage cross-functional teams in a dynamic, fast-paced environment.
• Exceptional written and verbal communication skills for clear documentation, presentations, and discussions.
• Demonstrated commitment to quality and continuous improvement, with a proactive approach to identifying and addressing regulatory challenges.

Why This Role Is Important

In this leadership position, you will drive compliance efforts across the organization, ensuring that all products are designed, developed, and released in compliance with global standards. Your role will be central in shaping the regulatory strategies that enable the company to enter global markets and maintain regulatory excellence.

Equal Opportunity Employer

We are committed to fostering an inclusive and diverse workforce. We encourage applications from candidates of all backgrounds and experiences.