Quality control Inspection coordinator (Mumbai)

Head – Quality & Regulatory Affairs

This is a strategic leadership appointment reporting directly to the Chairman & Managing Director – a rare chance to shape quality culture, build global regulatory frameworks, and drive operational excellence at an organisation scaling aggressively into regulated markets across USA, Europe, Japan, and China .

Certifications: EN ISO 13485, GMP Manufacturing

Exports to USA, Europe, Japan, China

The organisation is in a significant growth phase , expanding export operations into highly regulated markets. This creates an urgent need for a world-class quality and regulatory leader who can build systems, own compliance strategy, and represent the organisation to global regulatory authorities.

Title: Head – Quality & Regulatory Affairs

Travel: Occasional domestic and international travel

Compensation: ₹70-100 LPA++ (Competitive with market benchmarks)

Build, lead, and institutionalise a robust Quality Management System (QMS) and global regulatory framework across products, plants, and markets – ensuring first-time-right quality and full compliance with ISO 13485, USFDA, WHO-PQ, and EU MDR/IVDR requirements.

This is NOT a compliance role – this is a quality transformation and regulatory strategy leadership role .

Quality Management Establish and maintain a robust Quality Management System (QMS) compliant with ISO 13485, USFDA, WHO-PQ, and EU MDR/IVDR regulations Implement effective quality control processes throughout the manufacturing cycle – raw material inspection, production monitoring, and final product release Define and track key quality metrics (defect rates, customer complaints, non-conformance incidents) to drive continuous improvement Conduct regular internal audits and coordinate external audits by regulatory bodies and certification agencies

Regulatory Compliance Stay updated on the latest regulatory requirements and standards relevant in countries/regions where products are marketed Ensure timely submission o Apply on Kit Job: kitjob.in/job/4n8k6z