The successful candidate will possess the following attributes:
- Minimal of ten years' directly relatable experience, with a career in RA showing continuous advancement.
- Over five years of team leadership and management in a complex environment
- Experience in leading Regulatory Affairs and Quality Assurance functions in support of Molecular Diagnostics, IVD Molecular Biology, Diagnostics, Genomics products to market
- Native Korean speaker -with strong understanding of English language
- First class scientific education, ideally specialising in Molecular Biology/ Biotech gained in an internationally respected top tier university
Key deliverables of the successful candidate will include:
- Establish the RA/ QA operational plan for the product portfolio- at all times focusing on best quality regulatory filings that shorten time to market
- Design and ensure a world-class QA program and team underpins the requisite quality assurance requirements
- Directs functional activities designed to achieve rapid worldwide clearance/approval/registration of products with desired claims.
- Proven success in preparation and filing of complex Molecular Diagnostics/ IVD / Medical Device submissions.
- Represents molecular diagnostic/ IVD interests in key interactions/negotiations with relevant regulatory agencies
- Undertake a proactive role in external efforts to develop standards of strategic importance to and to influence policy-making bodies. interests in key interactions/negotiations with regulatory agencies
- Work with key stakeholders - including R&D, Leadership, Sales and Marketing and various regional and global authorities - to
- Passionate about how Life Sciences can improve the Human Kind