Regulatory Specialist

Job Title: Regulatory & Technical Writer

Experience

1–2 years (hands-on ownership in Regulatory [CDSCO, ISO, FDA] documentation)

About the Role

We are seeking an experienced Technical Writer to support our AI team with regulatory and compliance documentation for AI-enabled medical devices and software (SaMD). This role focuses on creating, maintaining, and managing documentation required for FDA submissions and EU MDR compliance, while collaborating closely with AI engineers, quality, regulatory affairs, and clinical teams.

You will play a critical role in ensuring our AI systems are clearly documented, auditable, and compliant with global regulatory standards.

Key Responsibilities

• Author, review, and maintain regulatory documentation for AI/ML-based medical devices and SaMD
  
• Support FDA submissions (e.g., 510(k), De Novo, PMA) and EU MDR technical documentation
  
• Develop and maintain documents including:
  
• Software Description and Architecture
  
• AI/ML model lifecycle documentation
  
• Risk management files (ISO 14971)
  
• Software Development Life Cycle (IEC 62304)
  
• Usability engineering documentation (IEC 62366)
  
• Clinical evaluation support documentation
  
• Model performance, validation, and verification reports
  
• Change management and traceability documentation
  
• Document AI model training data, data governance, bias considerations, and performance monitoring
  
• Collaborate with Regulatory Affairs, Quality, AI engineers, and Product teams to ensure alignment with regulatory expectations
  
• Ensure traceability between requirements, design, implementation, verification, and validation artifacts
  
• Support audits, inspections, and regulatory questions by providing clear and defensible documentation
  
• Maintain documentation in accordance with Quality Management Systems (QMS)
  

Required Qualifications

• Bachelor’s degree in Technical Communication, Biomedical Engineering, Computer Science, Life Sciences, or related field
  
• 3+ years of experience writing regulatory or quality documentation for medical devices or SaMD
  
• Hands-on experience with FDA and/or EU MDR regulatory submissions
  
• Strong understanding of regulated documentation requirements and controlled document processes
  
• Excellent technical writing, editing, and document management skills
  
• Experience working within a QMS (ISO 13485 preferred)
  

Preferred Qualifications

• Experience documenting AI/ML systems in regulated healthcare environments
  
• Familiarity with:
  
• FDA guidance on AI/ML-enabled medical devices
  
• EU MDR Annex II & III Technical Documentation
  
• GMLP (Good Machine Learning Practice)
  
• Understanding of model validation, dataset documentation, and post-market surveillance for AI systems
  
• Experience collaborating with Regulatory Affairs and Quality teams
  
• Familiarity with tools such as eQMS, document control systems, and requirements management tools
  

Nice to Have

• Experience with clinical AI, imaging AI, or decision support systems
  
• Exposure to cybersecurity documentation (FDA, IEC 81001-5-1)
  
• Ability to create traceability matrices, diagrams, and regulatory-ready visuals
  
• Prior experience supporting audits or regulatory inspections
  

What We Offer

• Opportunity to work on AI technologies that impact patient care
  
• High ownership role in regulatory readiness and compliance strategy
  
• Collaborative environment with AI, clinical, and regulatory experts
  
• Competitive compensation and benefits
  
• Flexible work arrangements
  

Must Have

·        Exposure to the MDR AI framework is highly desirable. Also, a strong background in technical writing is required, with experience in participating in at least two audits