บริษัท ไทยนิปปอนรับเบอร์อินดัสตรี้ จำกัด ( มหาชน )

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Apr 2, 2025

Regulatory Affairs Asst. Manager

Location

Pinthong Industrial Estate 1 Chon Buri

Salary

Based on company’s structure

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Job Descriptions

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.

Qualifications

Bachelor’s Degree in Science, Engineering or related technical field
3+ years of Regulatory Affairs experience within medical device or other highly regulated
Strong working knowledge of Quality System Regulation, ISO 13485, EU MDR, CE Mark, FDA medical device regulatory requirement and country-specific requirements
Working knowledge of FDA, ISO, EU and other applicable regional regulations for handling complaints, reporting incidents, and implementing CAPA
Good Command of English Language
TOEIC score of 650+ will be prioritized