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