We are currently seeking a RA Manager for a leading healthcare company, covering Thailand market. 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: Director, Regulatory Affairs
Location: Thailand
Main Country Converage: Thailand
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 Thailand 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 regulatory experience in the medical device industry.
- 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
