Senior Manager - Quality & Regulatory

Job Title Senior Manager - Quality & Regulatory Job Description Role Overview The SQR Lead will serve as the Quality and Regulatory leader for Oral Healthcare sustaining, lifecycle-management and product-development activities supported from Pune. The role will partner with global OHC R&D, Procurement, Operations and Quality & Regulatory teams to strengthen product quality, regulatory compliance, supplier quality performance and effective portfolio execution, ensuring the delivery of safe, effective, and compliant OHC products throughout the product lifecycle. The leader will support quality strategy, regulatory deployment, risk management, governance and continuous improvement while building a capable, high-performing SQR team.   The Product Safety Quality Manager 70 is responsible for conducting seamless, in-depth safety assessments and compliance evaluations of product designs, overseeing the analysis of test data and root cause analysis to effectively resolve complex safety issues. The role acts as a principal advisor and subject matter expert on product safety and compliance matters, provides authoritative guidance to internal teams and external stakeholders. The role reviews and enhances product safety processes and procedures, optimizes operational efficiency and resource allocation to achieve departmental objectives effectively.   Key Responsibilities • Lead the OHC Quality and Regulatory function in Pune as a site leadership-team member, fostering a culture of quality, compliance, accountability and continuous improvement across the site. • Provide oversight of the Quality Management System and ensure alignment with applicable global requirements, including FDA QMSR, ISO 13485, EU MDR and other relevant regulatory and quality standards. • Serve as the primary site Quality representative for leading and supporting the regulatory inspections, notified-body assessments and external audits, while maintaining organizational audit readiness and ensuring timely, effective responses. • Establish, maintain and continuously improve quality processes, systems, procedures and controls that support safe, effective, reliable and compliant products throughout their lifecycle. • Lead design assurance and design control activities, including design inputs, quality planning, verification, validation, usability, reliability, manufacturability, safety, design transfer and process validation across hardware, software and system development. • Ensure quality engineering documentation, including product and system quality plans, is accurate, current, risk-based and compliant with internal and external requirements. • Guide product and process risk-management activities across development, manufacturing and post-market phases, ensuring risks are identified, assessed, controlled and monitored throughout the lifecycle. • Lead & support investigations, root-cause analysis, CAPA, nonconformance management and corrective actions, ensuring sustainable resolution of product, process and quality-system issues. • Integrate customer feedback, reliability information, complaint trends and post-market surveillance data into product-development and lifecycle decisions, providing actionable feedback to design and manufacturing teams. • Monitor quality-system, product and process performance metrics, using data-based insights to identify trends, manage emerging risks and drive strategic improvement priorities. • Partner with R&D, Operations, Regulatory Affairs, Procurement and other functions to resolve quality issues, support business objectives and ensure effective execution of quality strategies and project milestones. • Lead supplier-quality governance, including supplier qualification and development, audits, quality agreements, supplier chang