Bengaluru Karnataka Ai engineer iii Jobs – 111 Open Jobs Today

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Regulatory Specialist

Teleradiology Solutions (TRS)
Bengaluru, Karnataka

Apply Now

Job details

Full-time

Qualifications

Quality Management
Writing skills
Quality management
Diagnostic evaluation
Bachelor's degree
Machine learning
Requirements management
Technical writing
AI
Document management
Editing
Technical Writing
FDA regulations
SDLC

Full job description

Job Information

Industry Health Care
Date Opened 07/14/2026
Job Type Full time
Work Experience 1-3 years
City Bangalore North
State/Province Karnataka
Country India
Zip/Postal Code 560048

Job Description

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

Apply Now

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