Getinge - Senior Manager - Quality & Regulatory

Overview:The Senior Manager Quality and Regulatory Compliance will lead the Quality and Compliance functions at the India Innovation Center (IIC) in Bangalore. As part of the Getinge India leadership team, this role is responsible for building, implementing, and managing a robust Quality Management System (QMS) that aligns with global regulatory standards.This individual will provide strategic direction, ensure compliance with applicable international regulations (FDA, ISO13485, MDSAP, QSR), and foster a culture of quality, accountability, and continuous improvement across the organization.Key Leadership:- Develop and execute the Quality and Regulatory strategy for the India Innovation Center in alignment with corporate objectives.- Establish, implement, and maintain a compliant and effective Quality Management System (QMS) tailored for R&D and product development operations.- Act as the Management Representative for Quality and Regulatory functions within the IIC.- Drive initiatives for continuous improvement and operational excellence in quality processes.Quality System Management:- Build and nurture a competent Quality organization that supports business objectives while ensuring adherence to global standards and regulatory requirements.- Lead implementation and certification efforts for ISO 13485 and MDSAP, ensuring compliance with FDA and EU regulatory frameworks.- Oversee internal and external audits (including FDA, ISO, and corporate audits) and ensure timely closure of findings and CAPAs.- Develop quality metrics, performance indicators, and management reports to monitor system effectiveness and business alignment.Compliance and Risk Management:- Ensure all business operations, design controls, and documentation meet regulatory and company standards.- Authorize product or process holds where compliance or safety concerns arise.- Manage risk assessments, corrective/preventive actions (CAPA), and non-conformance investigations.- Provide compliance leadership during third-party audits and regulatory inspections.Leadership & Stakeholder Management:- Serve as a key member of the IIC leadership team, partnering cross-functionally with R&D, Operations, Regulatory, and Global Quality teams.- Lead organizational change management initiatives to embed a strong quality and compliance mindset.- Build credibility and trust with internal teams and external partners through transparent communication and consistent delivery.- Mentor and develop team members to enhance technical and leadership capabilities.Operational Excellence:- Drive the implementation of digital and process-based improvements in quality systems.- Ensure departmental budgets are aligned with strategic goals and cost optimization.- Support product lifecycle processes including design verification, validation, and risk management.Qualifications & Bachelors degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.Experience: Minimum 15 years of progressive experience in Quality Assurance and Regulatory Compliance, preferably within the medical device industry.- Proven ability to build or transform a Quality organization in an innovation or R&D environment.- In-depth knowledge of FDA QSR, ISO 13485, MDSAP, and EU MDR regulatory frameworks.- Experience in managing third-party audits, CAPA systems, and quality risk management.- Strong business acumen and startup mindset ability to build systems from the ground up while planning for future scalability.- Demonstrated experience in leading teams and managing cross-functional projects. (ref:iimjobs.com)