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 workplace. 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 clear, 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).

Contribute to usability testing and incorporate feedback to improve documentation clarity.

Participate in internal and external audits related to product documentation.

Leadership

Set the documentation standard for the organisation and review work across teams.

Mentor junior writers; ensure consistency and quality across all deliverables.

Partner with R&D;, Regulatory Affairs, Clinical Affairs, QA, and Product Management to gather and validate technical information.

Requirements

5+ years of technical writing experience, with significant time in a regulated medical device or safety-critical software environment.

Proven FDA experience—hands-on authoring of documentation for FDA submissions (510(k) preferred).

ISO fluency—working knowledge of ISO 13485, ISO 14971 (risk),



and IEC 62304 (software lifecycle).

Strong understanding of design controls, risk management, and document control practices.

Proficient writing for regulated environments—SOPs, IFUs, and validation documentation.

Familiarity with document control systems, eQMS platforms, and tools such as Microsoft Office Suite and Confluence.

Exceptional attention to detail and ability to manage multiple priorities under strict timelines.

Excellent English writing and editing; ability to work directly with engineers and regulatory leads.

Bachelor's or Master's in Biomedical Engineering, Life Sciences, Technical Communication, or a related discipline.

Preferred Experience

Certification in Regulatory Writing, Medical Writing, or Technical Communication.

Experience with SaMD (Software as a Medical Device) or digital health applications.

Familiarity with cardiac / ECG or diagnostic devices.

Exposure to EU MDR, MDSAP, CDSCO technical files, UDI, and eIFU requirements.

Working knowledge of the Common Technical Document (CTD) format.

Knowledge of API documentation and software development workflows (Agile).

Awareness of HIPAA and GDPR data-handling requirements.

Familiarity with visual content and diagramming tools.

Role Details

Type: Full-Time · On-site

Location: Chennai, Tamil Nadu

Level: Senior — sets documentation standards and mentors writers

Pay: ₹15,000.00 - ₹30,000.00 per month

Experience:

- Technical writing: 3 years (Preferred)

Work Location: In person

📌 Senior Technical Writer (India)
🏢 Rhythmrx
📍 India