Senior Compliance Officer

1 week ago

kanpur, India beBeeQualityGovernance Full time

Job OverviewThe primary objective of this role is to fortify our compliance framework, enhance documentation systems, oversee audits, drive supplier quality governance, and ensure seamless alignment with international medical device standards, encompassing ISO 13485, MDR, MDSAP, and FDA 21 CFR Part 820.This position involves overseeing the Quality Management System (QMS) to guarantee it consistently meets global regulatory requirements, directing internal audits and coordinating external assessments conducted by regulators, notified bodies, and customers, strengthening the Corrective Action and Preventive Action (CAPA) program with systematic Root Cause Analysis (RCA), preventive actions, and structured closure of observations, maintaining documentation integrity, record-keeping systems, version control, and regulatory traceability, evaluating and developing suppliers through audits, SCAR/CAPA follow-up, and performance tracking, collaborating with Research and Development (R&D), Manufacturing, Clinical, Regulatory, and other teams to bridge gaps and enhance system robustness, facilitating training on QMS procedures, compliance expectations, and investigative methodologies, reviewing quality metrics and initiating continuous improvement projects across the organisation.

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