Regulatory Engineer

4 days ago

Bengaluru India Cyient Full time

Job Description Responsibilities - Lead preparation of Compliance Data Reports (CDRs) and Test Report Forms (TRFs) to demonstrate compliance with IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417, eIFU Regulation (EU-2021/2226), EU MDR [2017/745], UKCA, Canadian (SOR/98-282), and Australian (TGR) medical device regulations. - Analyze historical Request for Change (RfS) and design change data to develop and maintain regulatory compliance checklists and criteria for software medical device documentation. - Perform systematic gap assessments on change records and documentation to identify compliance risks, deficiencies, and areas for improvement per current regional and international requirements. - Develop, document, and execute remediation plans and associated Regulatory Affairs (RA) deliverables, such as updated DHF/technical files, risk management, usability, and labeling documentation. - Work cross-functionally with product development, engineering, quality, and clinical teams to embed compliance considerations into all processes. - Monitor ongoing global regulatory updates and proactively update internal processes and product files. - Support and lead internal audits, reviews, and preparations for external audits by notified bodies and competent authorities. - Liaise with global regulatory agencies and notified bodies for submissions, clarifications, and product registrations as needed. Experience - Minimum 35 years of professional experience in regulatory affairs, quality assurance, or compliance for medical devices; at least 12 years focused on Software as a Medical Device (SaMD) or medical device software. - Hands-on experience preparing technical documentation, gap assessments, and compliance reports for the EU, US, and other key markets. - Practical knowledge of the cited standards (IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417), and global device regulations (EU-MDR, UKCA, Canadian, and Australian frameworks). - Experience in change management, risk assessment, and nonconformance remediation in a regulated environment. - Strong organizational, documentation, and cross-functional communication skills. - Familiarity with electronic QMS and regulatory document management platforms is advantageous. Key Competencies - Detailed understanding of medical device development lifecycles, quality systems, and regulatory science for medical software. - Strong analytical abilities for reviewing design changes, identifying compliance gaps, and formulating action plans. - Excellent written and verbal communication skills for preparing high-quality submissions and interacting with global teams or regulators. - This role is ideal for professionals aiming to ensure best-in-class compliance and regulatory alignment for medical device software in an evolving regulatory environment. Educational Background Bachelor's degree Mechanical Engineering, Life Sciences, Computer Science, Regulatory Affairs, Biomedical Engineering Advanced certifications (e.g., Regulatory Affairs Certification, ISO 13485 lead auditor, etc.) are a plus.

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