Job Title: Regulatory Affairs Specialist – Software as a Medical Device (SaMD)

Location: Bengaluru Contract Type: Full time, Onsite Experience Required: 5 Years CTC- 9,00,000 Per Annum Role Overview

We are seeking an experienced Regulatory Affairs professional to lead and support regulatory strategy, submissions, and compliance activities for our Software as a Medical Device (SaMD) products. The ideal candidate has a strong background in medical device software regulations and a track record of successfully bringing digital health products to market. Key Responsibilities

Develop and execute regulatory strategies for SaMD products across target markets (US, EU, and other applicable regions).

Prepare, review, and submit regulatory filings, including FDA 510(k), De Novo, or PMA submissions.

Prepare and maintain Design History File (DHF) documentation, Technical Documentation, Software File, and regulatory deliverables throughout the product lifecycle.

Classify software products per IMDRF/FDA SaMD risk categorization and applicable regional frameworks (e.g., EU MDR Rule 11).

Ensure compliance with IEC 62304 (medical device software lifecycle), Design Control activities in accordance with FDA QMSR (21 CFR Part 820), ISO 13485, and applicable international regulations, IEC 82304-1, ISO 14971 (risk management).

Collaborate with R&D;, software engineering, quality, and clinical teams to ensure regulatory requirements are integrated throughout the product development lifecycle (including Agile/SDLC processes), including design reviews, sprint planning, software change assessments, release planning, and software configuration management.

Support review, and maintain regulatory and technical documentation including Software Requirements Specification (SRS),



Software Architecture Document (SAD), Software Design Specification (SDS), Traceability Matrix (RTM), Software Verification & Validation documents, Cybersecurity documentation, Risk Management File, Usability Engineering File, and Technical Documentation.

Monitor and interpret evolving global regulations and guidance related to SaMD, AI/ML-based medical software, cybersecurity, and interoperability (e.g., FDA's AI/ML SaMD Action Plan, EU MDR/IVDR updates).

Support post-market surveillance activities, including complaint handling, adverse event reporting, and software update/change control assessments (e.g., FDA's guidance on software modifications).

Act as a liaison with regulatory authorities and notified bodies; manage responses to regulatory queries and audits - Support regulatory inspections, ISO audits, internal audits, supplier audits, and maintain audit readiness.

Provide regulatory input during risk assessments, labeling, and cybersecurity risk management (per FDA premarket cybersecurity guidance) -Risk Management activities including Risk Management Plan, Hazard Analysis, Software FMEA, Benefit-Risk Analysis, Risk Control Verification, and Risk Management Report in accordance with ISO 14971.

Support Human Factors and Usability Engineering activities in accordance with IEC 62366-1 Required Qualifications

Minimum 5 years of regulatory affairs experience,



with significant exposure to Software as a Medical Device (SaMD) or connected/digital health products.

Bachelor's degree in Life Sciences, Biomedical Engineering, Computer Science, or a related field (advanced degree preferred).

Demonstrated experience with FDA and EU MDR regulatory pathways for software-based medical devices.

Strong working knowledge of IEC 62304, ISO 14971, ISO 13485, and IEC 82304-1, IEC 62366-1, IEC 81001-5-1, FDA Cybersecurity Guidance, IMDRF SaMD guidance, FDA QMSR, and applicable software validation guidance.

Experience with Agile software development environments and integrating regulatory requirements into DevOps/CI-CD pipelines is a plus.

Experience with Secure SDLC, Software Configuration Management, DevOps/CI-CD environments, Requirements Traceability, and software release management.

Familiarity with AI/ML-enabled medical device regulations and evolving guidance (e.g., Predetermined Change Control Plans).

Excellent written and verbal communication skills, with experience authoring regulatory submissions and interacting with health authorities.

Strong project management skills with the ability to manage multiple submissions/timelines simultaneously.

RAC certification (Regulatory Affairs Certification) is a plus.

Preferred

Skills

Experience with cybersecurity risk management frameworks for medical devices (e.g., AAMI TIR57, FDA premarket cybersecurity guidance).

Knowledge of interoperability standards (HL7 FHIR, IEEE 11073).

Experience working with Notified Bodies and international regulatory bodies (e.g., Health Canada, TGA, PMDA).

Background in clinical evaluation and clinical evidence generation for software-based devices.

📌 Regulatory Affairs Specialist – Software as a Medical Device (SaMD) (Bengaluru)
🏢 NexorTest Technologies
📍 Bengaluru