A global engineering and technology solutions provider specializing in digital, manufacturing, GIS and semiconductor services.
Provide regulatory leadership during product changes and updates, assessing regulatory impact of software modifications, AI/ML updates, and algorithm changes under MDR change control expectations.
Mentor and guide cross-functional teams on SaMD regulatory best practices, fostering a strong compliance culture across R&D, QA, clinical, and product management functions.
Drive Clinical Evaluation and Performance Evaluation activities for SaMD, collaborating with clinical, data science, and product teams to ensure clinical evidence, PMCF, and real-world performance data meet MDR expectations.
Interpret and apply MDCG guidance, harmonised standards, and common specifications relevant to SaMD, translating regulatory updates into actionable compliance strategies.
Act as the primary regulatory interface with Notified Bodies and Competent Authorities, managing audits, technical file reviews, deficiency responses, and regulatory communications.
Contribute to global regulatory strategy and lifecycle optimisation, supporting EU MDR alignment with other jurisdictions (e.g., FDA, IMDRF) to enable efficient international market access
Ensure alignment between regulatory requirements and software development lifecycle (SDLC) activities per IEC 62304, IEC 62366 & ISO 14971, including cybersecurity, validation, usability engineering, and change management under a QMS framework.
Lead EU MDR regulatory strategy for Software as a Medical Device (SaMD) across the full product lifecycle, including classification, conformity assessment pathways, and technical documentation planning in line with MDR (EU) 2017/745.
Own and maintain SaMD technical documentation, ensuring compliance with Annex II and III requirements, including software description, intended purpose, architecture, SOUP management, and traceability.
Support risk management and post-market surveillance for SaMD, including PMS planning, PSUR preparation, vigilance reporting, and continuous benefit-risk assessment.
Experience- 4+ experience in Regulatory affairs with atleast 4+ years in SaMDs
Education - B.Tech, M.Tech, B. Pharm., M. Pharm.