Regulatory Compliance Director (Medical Device)

Location: Thailand
Discipline: Life Sciences
Job type: Permanent
Salary: Competitive package & excellent culture
Contact name: Shashtidaran Prasanan

Contact email: shashtidaran.prasanan@atomicgroup.sg
Job ref: 958_1729237800
Published: 6 months ago

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.

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