Regulatory & Technical Writer

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