RA Specialist China/Hong Kong

About the position

The RA Specialist for China/Hong Kong at Intuitive Surgical is responsible for ensuring regulatory compliance for medical devices in the China market. This role involves collaborating with cross-functional teams to manage regulatory affairs activities, maintain regulatory filings, and support product registration applications. The specialist will act as the project lead, coordinating regulatory strategies and timelines, and ensuring compliance with local regulations throughout the product lifecycle.

Responsibilities

• Act as the RA project lead for China product registration applications with minimal oversight.
• Coordinate regulatory and clinical strategy development and timeline establishment.
• Provide explanations on China regulatory requirements to supportive teams for NMPA submissions.
• Support activities related to Product Technical Requirement (PTR) draft and type testing.
• Write and review sections of regulatory dossiers.
• Coordinate with stakeholders for regulator communications and consultations.
• Create and maintain a Tracker for submission deliverables and deficiency responses.
• Manage the China Regulatory Project Executive Summary for responsible projects.
• Support internal and external audits related to China compliance.
• Assist in China localization projects and support post-market team in PSUR generation.

Requirements

• Minimum 3 years of regulatory affairs experience required.
• Demonstrated understanding of NMPA medical device regulatory requirements and US FDA requirements.
• Experience with new product development projects for complex products.
• Strong verbal and written communication skills for effective regulatory submissions.
• Good interpersonal skills for cross-functional teamwork.
• Solid project management skills with experience in strategy development and execution.
• Proficient in Microsoft Word, Excel, and Project applications.

Nice-to-haves

• Knowledge of SaMD and SiMD is a plus.
• Minimum 1 year of experience supporting international submissions preferred.
• Previous China regulatory affairs experience is a major plus.
• Experience with RIMS (e.g., Veeva, Rimsys) is a plus.
• Cross-cultural (China) RA project experience is a plus.
• RAC (Regulatory Affairs Certified) is desirable.
• Ability to speak and write in Chinese is a plus.
• Knowledge of SAP, Agile, or similar business systems is desired.

Benefits

• Market-competitive compensation packages including base pay, incentives, benefits, and equity.