RAQA Executive

at  MERIT MEDICAL SINGAPORE PTE LTD

ABOUT THE COMPANY

Founded in 1987, Merit Medical Systems, Inc. (NASDAQ: MMSI) is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

Subject matter expert in the current regulatory requirements and strategies for the South-east Asia (SEA) countries, namely Singapore, Malaysia, Indonesia, Thailand and Vietnam.
Responsible for the daily operations of regulatory affairs and ensuring regulatory compliance within SEA countries stated above. Obtaining the regulatory approvals from government agencies for commercial distribution of Merit’s Medical Devices. Conducting product change assessment and obtaining the approval for the reportable changes.
Handling product complaints and managing adverse event reporting and any product recalls.