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 :

Compliance and Risk Management :

Leadership & Stakeholder Management :

Operational Excellence :

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.

(ref : iimjobs.com)