RAQA Specialist

About the Company

As a global medical device company originating from Japan, we pursue reliable quality and technology to contribute to healthcare in more than 160 countries and regions around the globe. We promise to walk alongside healthcare professionals to continue to make great contribution to society, now and into the future.

Key Functions / Responsibilities

• Responsible for maintaining the registration of medical device products in Singapore, Malaysia, Myanmar, Sri Lanka, Bangladesh, Cambodia, Laos, Brunei, Nepal, Maldives, Bhutan, and the East Timor market.
• Involved in registration dossier preparation and compilation, submission, follow-ups, monitoring, and obtaining approvals.
• Liaise and negotiate with various regulatory authorities when necessary to ensure successful registration within the required timeframe.
• Handle product complaints and report adverse events or non-c...