About the Role: We are seeking a motivated and detail-oriented QMS & Regulatory Affairs Specialist to join our growing regulatory team. This position is ideal for individuals with 1–5 years of experience in medical devices, particularly those familiar with Software as a Medical Device (SaMD) . You will play a key role in ensuring compliance with global regulatory requirements and maintaining an effective Quality Management System (QMS). Responsibility: Support implementation and maintenance of ISO 13485:2016 compliant QMS processes. Assist in regulatory submissions (e.g., FDA 510(k) , EU MDR , India CDSCO ) for SaMD and other medical devices. Prepare and maintain regulatory documents including technical files, design dossiers, and labeling materials. Collaborate with cross-functional teams (engineering, product, clinical) to ensure regulatory and quality compliance from design through post-market. Support risk management activities in line with ISO 14971 and software lifecycle documentation under IEC 62304 . Conduct internal audits, gap assessments, and assist in external audits or inspections. Maintain QMS documentation including SOPs, work instructions, CAPAs, and training records. Track and interpret changes in regulatory standards and implement updates accordingly. Required Skills Bachelor’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field. 1–5 years of relevant experience in QMS and regulatory affairs within the medical device or SaMD domain . Good understanding of ISO 13485 , IEC 62304 , ISO 14971 , and related standards. Exposure to regulatory pathways in FDA, EU MDR, and/or CDSCO . Strong technical writing skills Detail-oriented with excellent communication

Technical Lead Key Responsibilities: ● Lead and mentor cross-functional teams including backend, frontend, and DevOps engineers. ● Drive backend development initiatives, with hands-on support in Java-based systems. ● Design and maintain RESTful APIs that are scalable, secure, and performant. ● Manage relational databases and write efficient SQL queries. ● Oversee containerized deployments using Docker and cloud-native environments, preferably AWS. ● Implement and enforce Git-based version control workflows. ● Allocate and track tasks, ensuring timely and quality delivery of features and fixes. ● Collaborate with Product and Architecture to define and refine requirements. ● Drive code reviews, architecture discussions, and engineering best practices. Requirements : ● 5-7 years of software development experience with strong backend knowledge on Java Spring Boot ● Solid understanding of RESTful services and API design. ● Proficient in working with SQL databases like PostgreSQL or MySQL. ● Experience with Docker and AWS services is a strong plus. ● Familiarity with Git version control and branching strategies. ● Strong organizational and communication skills, with a track record of successful project delivery. Preferred Qualifications: ● Experience working with remote and distributed teams. ● Exposure to CI/CD pipelines and DevOps tooling. ● Prior experience integrating with frontend technologies (Angular, React, or similar) is a plus.