We are currently seeking a Regional Regulatory and Quality Assurance (RAQA) Specialist for a leading healthcare company, covering the SEA, ISC, and MEA regions. This pivotal role involves ensuring full regulatory and quality compliance for the company's medical device product portfolio prior to import and supply. The successful candidate will play an integral part in delivering regulatory outcomes, maintaining compliance standards, and supporting continuous improvement initiatives. This position offers a unique opportunity to shape regional strategies and contribute to advancing healthcare standards.
Reporting to: Associate Director, RAQA, Singapore
Location: Singapore
Main Country Converage: 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 with 5 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.
How to Apply:
Please provide your CV to Shash Prasanan at shashtidaran.prasanan@atomicgroup.sg, in either Microsoft Word document/pdf format.
EA License No. 23S1885
Registration No. R24121011
