Regulatory Affairs Specialist - Supporting China Product Registration

Intuitive•Peachtree Corners, GA

3d•$107,000 - $181,100•Onsite

About The Position

This role partners with the in-country RA team and other cross-functional teams to ensure the company's regulatory affairs activities are conducted accurately, ethically, and in compliance with the latest relevant regulations and standards for the China market throughout the product lifecycle. Responsibilities include maintaining regulatory filings and licenses, providing support to cross-functional teams for pre-market applications and post-market regulatory compliances.

Requirements

Minimum B.S/B.E or higher in life science, biomedical engineering, or related field.
Minimum 5 years RA experience with a bachelors or 3 years with a masters degree.
Experience with new product development projects for complex products.
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.
Solid project management skills, experience of working cross-functionally/regionally to support strategy development, drive planning and execute to time sensitive goals.
Keen on delivering quality results and introducing best practices.
Highly proficient in Microsoft Word, Excel, and Project applications.

Nice To Haves

Advanced degree preferred.
Software knowledge is a plus.
Minimum 2 years of working experience supporting international submissions preferred.
Previous China regulatory affairs experience is a major plus.
Experience with RIMS (e.g., Veeva, Rimsys, etc.) is a plus.
Cross-cultural (China) RA project related experience is a plus.
RAC (regulatory affairs certified) desirable.
Ability to speak and write in Chinese is a plus.
Knowledge of SAP, Agile or similar business systems desired.

Responsibilities

Serve as the RA Project point of contact for China product registrations and other regulatory filings.
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 for submission to regulatory authorities in China.
Assist in activities related to Product Technical Requirement (PTR) draft and type testing.
Maintain regulatory clearances and approvals, including necessary filings, archival, and communications.
Conduct global regulatory assessment (GRA) for the China market.
Stay informed of regulatory affairs guidelines in China and provide input on updated regulations and standards.
Provide regulatory input for the development of the Regulatory Intelligence Management System (RIMS).
Develop and maintain departmental procedures and database for regulatory affairs.
Participate in clinical evaluation study as needed.
Support the Approved Product List (APL) process.
Support post-market regulatory compliance activities, including PSURs.
Coordinate recall or market withdrawal activities as necessary.
Assist in product shipping block and release processes.
Aid the local RA team with government queries and registration documentation requirements.
Demonstrate flexibility as team priorities evolve and assist in updating project plans.
Contribute to departmental goals and perform other duties as required.