Plan, prepare, and execute necessary regulatory affairs actions to support business objectives in alignment with company business strategy
Job Summary
Plan, prepare, and execute necessary regulatory affairs actions to support business objectives in alignment with company business strategy.
Build regulatory strategies for assigned projects, such as new product introductions, and execute regulatory submissions by collaborating with overseas manufacturers and engaging with regulatory bodies like PMDA.
Ensure stable market supply of products by completing necessary internal processes and regulatory procedures in accordance with relevant laws and internal regulations for post-market change management and supply discontinuation.
Matching Summary
Plan, prepare, and execute necessary regulatory affairs actions to support business objectives in alignment with company business strategy.
Skills & Requirements
Must-have
Medical device regulatory affairs experience
English comprehension and communication
Regulatory strategy development
Post-market change management
Nice-to-have
Lead PMDA consultations
Support team members
Contribute to organizational projects
Key Requirements
5+ years medical device regulatory affairs experience