Job Title: Medical Software Documentation & Regulatory Specialist
Location: Bengaluru
Employment Type: Full time, In person, At office (5 days per week)
Company: Drongo AI Pvt Ltd
About Us:
Drongo AI is a technology enterprise that builds intelligent, cutting edge technology solutions to new-age challenges. We are passionate about developing innovative solutions that have tangible/high impact in fields such as healthcare, industrial automation, digital marketing, etc.
We are a medical technology company developing regulatory-grade medical software including RIS, PACS, modality/console software, and AI-based clinical tools.
Our software is deployed in clinical environments and must comply with global medical device regulations, including IEC 62304, ISO 13485, ISO 14971, CE-MDR, and CDSCO.
Role Summary:
We are looking for a Medical Software Documentation & Regulatory Specialist to own, create, maintain, and control all documentation required for medical software development, certification, and audits.
This role works closely with engineering, QA/RA, product, and project management to ensure that documentation is accurate, traceable, audit-ready, and aligned with real software behavior.
Key Responsibilities:
1) Medical Software Documentation Ownership:
- Create, maintain, and version-control documentation across product and service projects
- Own documentation including:
- Software Development Plans (SDP)
- Software Architecture & Design Documents
- Software Requirements Specifications (SRS)
- Risk Management Files
- Verification & Validation (V&V) documentation
- Traceability Matrices (RTM)
- Release Notes & Change Records
- Ensure documentation reflects actual implementation, not just theoretical processes
2) Regulatory & Standards Alignment:
- Ensure documentation compliance with:
- IEC 62304 – Medical Software Lifecycle
- ISO 13485 – Quality Management Systems
- ISO 14971 – Risk Management
- CE-MDR (Annex II & III)
- CDSCO medical device software requirements
- Support regulatory submissions, audits, and inspections
- Align documentation with SaMD classification and software safety classes (A/B/C)
3) Traceability & Change Control:
- Maintain end-to-end traceability: Requirement → Risk → Design → Test → Release
- Ensure change impact analysis is documented for:
- New features
- Bug fixes
- Customer-specific changes
- Manage document versioning, approvals, and sign-offs
4) Cross-Functional Collaboration:
Work closely with:
- Engineering teams to understand features & architecture
- QA/RA teams for audits and compliance reviews
- Project managers for release documentation
- Participate in sprint reviews and release planning to capture documentation updates in real time
5) Audit & Inspection Readiness:
Prepare documentation packages for:
- Internal audits
- External audits (Notified Body / CDSCO)
- Ensure documentation is consistent, complete, and defensible
- Support responses to audit findings and corrective actions
Required Skills & Experience:
Experience:
- 3–7+ years of experience in medical software documentation or regulatory affairs
- Proven experience working on regulated medical software products
- Experience supporting CE-MDR / CDSCO / ISO audits
- Hands-on experience with software lifecycle documentation
Technical & Domain Knowledge:
Strong understanding of:
- Software development lifecycle (Agile & Hybrid)
- Medical software verification & validation
- Risk management concepts for software
- Ability to understand technical inputs from developers (APIs, workflows, architecture)
Required / Preferred Certifications:
Strongly Preferred:
- IEC 62304 – Medical Software Lifecycle (Foundation / Practitioner)
- ISO 13485 Internal Auditor
- ISO 14971 Risk Management
Good to Have:
- CE-MDR Technical Documentation Training
- CDSCO Medical Device Regulatory Training
- SaMD Regulatory Certification
(Certifications are a plus; real-world regulated documentation experience is mandatory)
Soft Skills That Matter:
- Exceptional attention to detail
- Strong written communication skills
- Ability to translate technical content into regulatory-grade documentation
- Organized, methodical, and deadline-driven
- Comfortable pushing back when documentation gaps exist
What Success Looks Like in This Role:
- Zero major audit findings related to documentation
- Up-to-date, traceable, and consistent documentation across products
- Engineers and PMs confident in documentation readiness
- Smooth regulatory submissions and inspection
What We Offer:
- Work on real clinical medical software
- Exposure to full medical software lifecycle
- High-impact role critical to certification and compliance
- Competitive compensation
- Long-term growth in regulatory leadership roles
Pay: From ₹600,000.00 per year
Job Type: Full-time
Pay: From ₹600,000.00 per year
Education:
Experience:
- medical software documentation or regulatory affairs: 3 years (Preferred)
- regulated medical software products: 2 years (Preferred)
- CE-MDR / CDSCO / ISO audits: 1 year (Preferred)
Work Location: In person
