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About the Role:We are seeking a detail-oriented and proactive Regulatory and QMS Engineer with 2–3 years of experience in the medical device industry. The ideal candidate will be responsible for supporting regulatory submissions, maintaining compliance with applicable medical device regulations (e.g., MDR, CDSCO, FDA), and ensuring the effective implementation and maintenance of ISO 13485-compliant Quality Management Systems.Key Responsibilities:Regulatory Affairs:• Prepare, compile, and submit regulatory documents to national and international authorities (e.g., CDSCO, FDA, EU Notified Bodies).• Maintain up-to-date knowledge of medical device regulations and standards (ISO 13485, EU MDR, 21 CFR Part 820, etc.).• Support product registration, licensing, and post-market surveillance activities.• Assist in preparing technical documentation, Device History Files, and risk assessments.• Conduct Research on Regulatory Requirements and draft white papersQuality Management System:• Maintain and update QMS in accordance with ISO 13485:2016 and other applicable standards.• Support external audits (regulatory or certification bodies).• Monitor and track CAPAs, non-conformances, and change control processes.• Support the development, review, and implementation of SOPs, work instructions, and QMS procedures.• Collaborate with cross-functional teams to ensure quality and regulatory compliance during product development and lifecycle management.Qualifications & Skills:• Bachelor's degree in Biomedical Engineering, Life Sciences, Quality Management, or a related field.• 2–3 years of experience in regulatory affairs or quality management within the medical device industry.Preferred:• Experience working with SaMD and good understanding of IEC 62304. • Strong oral and written communication skills