Regulatory compliance director

1 month ago


Singapore Atomic Recruitment Full time

We are currently looking for a Global Regulatory Compliance Director in the medical device industry to join a global leader in cutting-edge healthcare solutions. Known for their dedication to innovation and operational excellence, they are focused on improving patient care and maintaining the highest regulatory standards across multiple regional sites. With a mission to standardize compliance and ensure quality across all operations, this is your opportunity to contribute to the transformation of healthcare on a global scale. Apply now to be part of this impactful journey. Reporting to: VP of Quality, Regulatory, and Assurance Location: Singapore Work mode: Full-time The role: Lead regulatory compliance efforts across multiple manufacturing sites, including conducting corporate audits and supporting critical external inspections (e.g., FDA, NMPA). Oversee Corrective and Preventive Actions (CAPA), remediation activities, and monitor QMS operations to identify and communicate compliance risks to leadership. Organize and lead global procedures, including QMS change management, regulatory notifications, and Global Management Reviews. Support critical business projects by providing regulatory compliance expertise and manage QMS-related IT systems. The experience: Bachelor degree in any science related field Ideally with 7-9 years of experiences on medical device Quality & Regulatory compliance management Knowledge on US FDA and other Health Authorities regulation, including ISO13485 Good experience with managing FDA inspection Ideally with strong internal stakeholder management How to apply:Please provide your CV to Shash Prasanan at , in either Microsoft Word document/pdf format.EA License No. 23 S1885Registration No. R24121011 #J-18808-Ljbffr



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