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1. Primary liaison for quality system management and regulatory affairs, interfacing with external (regulatory agencies, customers) and internal stakeholders.2. Ensure adherence to QMS policies and regulatory standards, including ISO 13485 and FDA guidelines.
We are hiring a Quality Manager/Sr. Manager to lead end-to-end quality functions at a state-of-the-art food manufacturing facility. This is a pivotal role ensuring compliance, continuous improvement, and product integrity. You'll work closely with leadership, production, and vendors to uphold global quality standards.
As the Quality & Regulatory Leader, you will be instrumental in establishing and managing the Quality & Regulatory Affairs function for new manufacturing plant in implant space in India. This role offers the rare opportunity to build processes, systems, and a team from the ground up and liase with our international team.
The Head of Regulatory Affairs - India will lead regulatory strategy and compliance efforts to ensure successful registration, approval, and lifecycle management of medical devices in alignment with both national and international standards. This senior role requires an experienced leader to manage regulatory submissions, engage with authorities like CDSCO, and drive cross-functional collaboration to support innovation, quality, and business objectives.
You will be responsible of managing, reviewing and overseeing relevant quality control (chemicals & microbiological) activities and practices by ensuring integrity and traceability of all generated data in accordance with the current SOPs and contributing to the development and implementation of quality standards /& principles.
The Regulatory Affairs professional would be responsible for handling dossiers for new products including biosimilars, innovators, and complex generics in India.
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