Regulatory Affairs Excecutive

*Fresh Graduates are welcome!*

Responsibilities:

• Responsible for regulatory activities and quality assurance in SE Asia
• Timely coordination and submission of product registration and follow up request i.e. new products, license renewals and product amendments. This would include product grouping and risk classification, and regular update of the database
• Post market surveillance – Monitor and review the report form of logging product complaints/feedback in the system (by the Sales Support team), and to ensure the FSCA (Field Safety Corrective Actions) is completed in timely manner according to the regulation
• Ensure the close out of FSCA through working with the respective country’s representatives and distributors with their country authority, follow up with the Sales Support team on the necessary close out
• Support and participate in the preparation and audit (such as GDPMDS) and help to maintain QMS system, provide support in the editing and reviewing of SOPs
• Analyze the VOC and complaints to create the QA reports
• Involve in projects collaboration across countries
• Traveling to embassy within Singapore to legalize documents
• Any other ad hoc duties as assigned

Requirements:

• Degree / Diploma in Life Sciences, Engineering, or related discipline
• At least 1 year of related working experience, preferably in the medical device /pharmaceutical / life sciences industry
• Possess good knowledge of regulations and requirements for medical devices, GDPMDS (Good Distribution Practice for Medical Devices), EU Medical Device Directive/ Regulation, US FDA guidance, ISO standards (13485, 9001)
• Knowledge and specialization in Regulatory and Quality Affairs (Quality Control/Assurance) is an advantage
• Excellent communication skills and English at work proficiency level (writing and conversational)
• Proficient in Microsoft Office
• Independent, meticulous, detail-oriented, and proactive
• Ability to Multi-task & Proactive
• Positive working attitude with passion to learn and develop
• Able to adapt in a fast-paced environment