Regional RAQA Specialist (Medical Device)

Reporting to:Associate Director, RAQA, Singapore

Location:Singapore

Main Country Coverage:Singapore, Malaysia & Thailand (Potential Future Coverage: Vietnam, Indonesia, Brunei and Laos)

The Role:

• Regulatory Compliance:Execute regulatory strategies for product registrations, license renewals, and amendments, while ensuring compliance with applicable regulations.
• Dossier Development:Prepare high-quality registration dossiers to achieve timely regulatory approvals.
• Risk Mitigation:Monitor submission progress, identify risks, and implement temporary or long-term countermeasures to address delays.
• Regulatory Intelligence:Stay updated on regulatory changes across the assigned regions and assess their impact on company operations.
• Post-Market Surveillance:Manage customer complaints, adverse events, FSRAs, and product recalls; ensure timely reporting to authorities.
• Quality System Support:Assist in establishing and maintaining GDPMD/GDP quality systems and participate in audits and continuous improvements.
• Engage with government agencies, trade associations, and channel partners such as distributors and consultants.

The Experience:

• Bachelor's degree in Bioengineering or related courses.
• Ideally with5 years of RA/QA experience in the medical device industry, preferably with regional responsibilities
• Good knowledge of regulatory guidelines and quality management systems.
• Good analytical thinking, problem-solving skills, and proficiency in MS Office and Adobe Acrobat.