- Robot type
- Surgical and Medical
- Location
- Peachtree CornersGeorgiaUSA
- Job type
- Manufacturing
- Posted
- Aug 21, 2026
Full-time
Regulatory Affairs Specialist - Supporting China Product Registration
Job description
Partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted accurately, ethically based upon the latest relevant regulations and standards, so that regulatory compliance against China requirement is ensured for all relevant aspects throughout the lifecycle of the products subject to China market. Additional responsibilities include maintaining regulatory filings and licenses. Provide support to cross-functional team, responsible for the assigned tasks pertaining to pre-market applications and/or post-market regulatory compliances.
Job responsibilities
- Serve as the RA Project point of contact when supporting China product registrations and other regulatory filings (e.g., green channel, priority review, etc.).
- Offer regulatory guidance on China regulatory requirements for new product development and product change projects.
- Prepare regulatory filing/submission documents and collaborate with the in-country regulatory team to submit them to regulatory authorities in China.
- Assist in activities related to Product Technical Requirement (PTR) draft and type testing when necessary.
- Maintain regulatory clearances and approvals, including necessary filings, archival, and communications.
- Conduct global regulatory assessment (GRA) for the China market in partnership with PLE and the in-country RA team.
- Stay informed of regulatory affairs guidelines in China and provide input on updated regulations and standards as needed.
- Provide regulatory input for the development of the Regulatory Intelligence Management System (RIMS).
Job requirements
- Education: Minimum B.S/B.E or higher in life science, biomedical engineering, or related field. Advanced degree preferred. Software knowledge is a plus.
- Minimum 5 years RA experience is required with a bachelors or 3 years with a masters degree.
- Minimum 2 years of working experience supporting international submissions preferred
- Previous China regulatory affairs experience is a major plus.
- Experience with new product development projects for complex products.
- Experience with RIMS (e.g., Veeva, Rimsys, etc.) is a plus.
- Excellent verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
- Good interpersonal skills and able to work well with cross- functional teams.