A new and exciting role has opened with a US-listed medical devices company. They are now looking for a RA/QA Director to lead their RA/QA team and play a pivotal role in driving their APAC business expansion plans.
Reporting into the VP of Regulatory and Quality, you will be responsible for the following across APAC regions:
- Establishing, implementing and maintaining Quality Management System and processes in relation to customer/product quality issues, supporting the needs of the business and ensure compliance to international standards and regulations
- Assume role as a Subject Matter Expert in CAPA management, tracking and reviewing of open CAPAs and ensure timely closure.
- Engage in regulatory intelligence: establish and implement appropriate regulatory strategies in accordance to various regulatory bodies across APAC regions to achieve successful approvals
- Keep abreast on regulations and quality standards updates in the industry. Provide advice to management team should any updates/changes impact products in the region and ensure implementation of resulting actions
- Drive improvements in APAC regions by collaboration and provision of relevant quality & regulatory knowledge and guidance to both internal and external stakeholders of the business
To qualify for this role you should have:
- Degree in Life Sciences or Bioengineering with at least 10 years of experience in highly-regulated industry, preferably in medical devices or IVD industries.
- Strong knowledge in ISO 13485. Able to lead internal audits will be a plus
- Prior work experience with distributors across the APAC regions and suppliers will be advantageous
- Knowledge in Mandarin, Japanese or Korean language will be a value-add
- Ability to travel frequently
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).