Senior Technical Writer

Regulatory & Product Documentation · Medical Devices & Digital Health | Full-Time | Chennai (On-site)

Job Summary

RhythmRx is hiring a Senior Technical Writer to own end-to-end documentation across our portfolio of connected cardiac monitoring devices and digital health solutions. You will develop, standardise, and maintain high-quality, submission-ready documentation—spanning regulatory filings, software and hardware manuals, and clinical user content. The role pairs hands-on authoring with documentation leadership: setting standards, owning document control, and serving as the documentation reference point in a regulated medical-device environment. Your work directly supports FDA and ISO compliance while ensuring clarity for clinicians, technicians, and patients.

Key Responsibilities

Regulatory & Compliance Documentation

Author and maintain FDA- and ISO-compliant documentation across the device lifecycle, including 510(k) submission inputs.

Develop documents aligned to IEC 62304, ISO 14971, and ISO 13485—SRS, Device Description, risk management file,



and Design History File (DHF) inputs.

Produce cybersecurity and compliance artifacts (§524B documentation, security-annotated specifications).

Maintain requirements-to-verification traceability for audit and submission readiness.

User & Product Documentation

Create explicit, user-centered content: clinical user manuals, operator guides, Instructions for Use (IFU), installation and configuration guides.

Document software and hardware behaviour, including API references, release notes, and setup workflows.

Translate complex technical and clinical input into structured content tailored to healthcare professionals, technicians, and internal stakeholders.

Standards, Control & Quality

Establish and enforce templates, style guides, versioning, and document control practices.

Manage documentation within version-management tools and Quality Management Systems (eQMS).

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📌 Senior Technical Writer (Ambattur)
🏢 Rhythmrx
📍 Ambattur