Seeking an experienced Regulatory Specialist with expertise in regulatory documentation for AI-driven medical devices.

About the Company

Teleradiology Solutions is a prominent player in the healthcare sector, specializing in advanced technology solutions for radiology and diagnostic imaging. The company adopts innovative approaches to healthcare, emphasizing compliance and regulatory standards to ensure the delivery of high-quality medical services.

Role Overview

We are seeking an experienced Regulatory Specialist to join our team, focusing on the regulatory and compliance documentation critical to the development and deployment of AI-enabled medical devices and software. The individual will work closely with various teams, including AI engineers, regulatory affairs, and clinical staff, to ensure adherence to stringent global regulatory standards.

Key Responsibilities

• Author, review, and maintain regulatory documentation necessary for AI/ML-based medical devices and software applications.
• Support submissions to the FDA (e.g., 510(k), De Novo, PMA) and technical documentation required for the EU Medical Device Regulation (MDR).
• Develop and maintain essential documents, including:
  • Software Description and Architecture
  • AI/ML model lifecycle documentation
  • Risk management files as per ISO 14971
  • Software Development Life Cycle documentation (IEC 62304)
  • Usability engineering documentation (IEC 62366)
  • Clinical evaluation support documents
  • Model performance, validation, and verification reports
  • Change management and traceability documentation.
• Maintain meticulous documentation regarding AI model training data, ensuring compliance with data governance, bias considerations, and performance monitoring.
• Collaborate with cross-functional teams to ensure alignment with regulatory requirements and facilitate audits and inspections.
• Responsibly manage and update regulatory documents in accordance with our Quality Management System (QMS), ensuring all documentation remains compliant and organized.

Tech Stack

• Regulatory documentation standards such as FDA and EU MDR.
• Quality Management Systems such as ISO 13485.
• Software Development Life Cycle (SDLC) methodologies.
• Tools for managing regulatory submissions and documentation control.

Salary

Estimated salary of ₹80,000 - ₹1,20,000 per month, commensurate with experience and industry standards.

Requirements

• Education: Bachelor’s degree in Technical Communication, Biomedical Engineering, Computer Science, Life Sciences, or related field.
• Experience: 3+ years of experience writing regulatory or quality documentation for medical devices or Software as a Medical Device (SaMD).
• Regulatory Knowledge: Hands-on experience with FDA and/or EU MDR regulatory submissions.
• Technical Skills: Strong understanding of regulated documentation requirements, excellent technical writing, editing, and document management skills.
• Quality Management: Experience working within a Quality Management System (QMS) such as ISO 13485 preferred.

Preferred Qualifications

• Experience documenting AI/ML systems in regulated healthcare environments.
• Familiarity with FDA guidance on AI/ML-enabled medical devices and EU MDR documentation requirements.
• Understanding of model validation and post-market surveillance.

Benefits

• Opportunity to work on pioneering AI technologies impacting patient care.
• Significant ownership role in regulatory compliance strategy.
• Collaborative team environment involving AI, clinical, and regulatory experts.
• Competitive salary and benefits.
• Flexible work arrangements.