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: Thailand (Chonburi)
- 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 shashtidaran.prasanan@atomicgroup.sg, in either Microsoft Word document/pdf format.
EA License No. 23S1885
Registration No. R24121011
