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

- Team-oriented 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