Quality & Regulatory Lead- Medical Devices
7 hours ago
About Our Client
Global medical devices client in the space of orthopedic implants
Job Description
Regulatory Affairs:Lead interactions with Indian health authorities (CDSCO) for the registration and continued compliance of our implants and instruments.Oversee the regulatory process for the new facility certification.Quality System & Compliance:Set up and maintain the Quality Management System in alignment with ISO 13485 and corporate standards.Ensure compliance with national and international medical device regulations.Process & Equipment Qualification:Coordinate the qualification of industrial processes and validation of new equipment for production.Clinical Affairs:Manage and coordinate clinical investigations for products, in collaboration with corporate teams.Team Development:Recruit, train, and manage a growing quality and regulatory team to support operations and scale with business needs.The Successful Applicant
Experience:8+ years in quality and/or regulatory roles within the medical device industry, ideally with Class II or III implants.Prior experience in greenfield or startup manufacturing environments is a strong plus.Skills & Attributes:Deep understanding of ISO 13485, CDSCO regulatory frameworks, and international medical device compliance.Hands-on leadership style with a willingness to build and scale operations from scratch.Strong communicator with cross-cultural collaboration skills.Passionate about quality and patient safety, with a mindset for continuous improvement.-
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