Regulatory Affairs Specialist - Supporting China Product Registration

📋 Description

• Partner with in-country RA, Product Localization Engineering, and cross-functional teams to ensure
• Maintain regulatory filings and licenses; support pre-market and post-market compliance tasks.
• Act as RA project contact for China product registrations and regulatory filings (e.g., green
• Provide regulatory guidance for new product development and changes to ensure submission
• Prepare filing/submission documents and collaborate with local RA teams to submit to Chinese
• Assist PTR draft and type testing when necessary.

🎯 Requirements

• Education: B.S./B.E. in life sciences; advanced degree preferred; software knowledge a plus.
• Minimum 5 years RA experience (3 years with masters).
• 2+ years supporting international submissions; China regulatory affairs experience is a major plus.
• Experience with new product development for complex products.
• Experience with RIMS (e.g., Veeva, Rimsys) is a plus.
• Excellent written and verbal communication; ability to translate technical docs to regulatory

🎁 Benefits

• Intuitive is an Equal Opportunity Employer.
• Market-competitive compensation with base pay, incentives, benefits, and equity.