หน้าที่ความรับผิดชอบ

รายละเอียดงาน
1. Provide accurate and consistent regulatory recommendations, decisions, and feedback
2. Prepare regulatory strategies for new devices and post market changes
3. Clearly communicate strategies to RA Manager and core teams
4. Prepare regulatory filings for new products, as well as significant post-market changes
5. As necessary, review complex regulatory issues with RA Manager
6. Identify risks within regulatory strategies and clearly communicate risks to project teams and RA Manager
7. Negotiate and lead meeting directly with government entities on regulatory filings at the reviewer level.
8. Lead and author multiple types of substantive regulatory filings such as PMAs, 510(k), EU Technical Document
9. Follow QS procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, MDSAP and UKCA
10. Review labeling, packaging and promotional materials to ensure regulatory compliance.
11. Maintain records of regulatory submissions and approvals.
12. Ensure the products comply with global regulations and reach the market legally and efficiently.
13. Additional responsibilities as assigned by the Regulatory Affairs Manager.

 

หมายเหตุ

- อัตรา : 1 อัตรา

ทักษะภาษาที่ 1 : อังกฤษ