Company Description NexorTest Technologies Pvt Ltd provides end-to-end solutions in product design, testing, and certification, helping organizations launch cutting-edge and reliable products that meet global standards. The company serves a wide range of industries, including aerospace, defense, commercial, railway, automotive, medical devices, telecom, IoT, and more. Its services span mechanical, electronics, and enclosure design, along with comprehensive gap analysis and documentation support.

NexorTest offers extensive testing capabilities, such as EMC/EMI, environmental and reliability, material, biocompatibility, and software lifecycle and cybersecurity testing. The organization also supports global regulatory pathways, including CE Marking and EU MDR, FCC, US FDA submissions, BIS, WPC, TEC, and other international market approvals.

Role Description The Regulatory Affairs Specialist – Software as a Medical Device will manage regulatory activities for software-based medical products, ensuring alignment with international standards and market-specific requirements. This full-time, on-site role in Coimbatore involves preparing and maintaining regulatory documentation, coordinating regulatory submissions, and supporting approvals for global markets. The specialist will work closely with design, testing, and certification teams to interpret regulatory requirements, guide product development for compliance, and maintain up-to-date knowledge of relevant regulations and guidance (e.g., EU MDR, FDA SaMD frameworks).





Daily responsibilities include reviewing technical files, risk management documentation, and cybersecurity and software lifecycle evidence, as well as supporting internal audits and responding to regulatory queries. The role also includes contributing to regulatory strategy, tracking changes in SaMD regulations, and providing training or guidance to internal stakeholders.

Qualifications

- Candidates should possess strong skills in Regulatory Affairs and Regulatory Compliance for SaMD.
- Candidates should possess skills in Regulatory Requirements interpretation and application across EU, US, and other key markets.
- Candidates should possess skills in Regulatory Documentation, including technical files, risk management, and software lifecycle records.
- Candidates should possess skills in Regulatory Submissions, including EU MDR, CE Marking, US FDA submissions, and other global approvals.
- Relevant experience with Software as a Medical Device (SaMD), software lifecycle standards (e.g., IEC 62304), and cybersecurity regulations.
- Familiarity with quality management systems (e.g., ISO 13485) and risk management standards (e.g., ISO 14971).
- Strong analytical, documentation, and communication skills, with the ability to collaborate effectively in cross-functional teams.
- Bachelor’s or master’s degree in engineering, life sciences, regulatory affairs, or a related discipline; prior experience in medical device or healthcare technology is preferred.

📌 Regulatory Affairs Specialist - Software as a Medical Device (Coimbatore)
🏢 NexorTest Technologies
📍 Coimbatore