Company Description NexorTest Technologies Pvt Ltd provides end-to-end solutions in product design, testing, and certification, helping organizations launch innovative 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 robust skills in Regulatory Affairs and Regula

📌 Regulatory Affairs Specialist (Coimbatore)
🏢 NexorTest Technologies
📍 Coimbatore