Regulatory Affairs Specialist (NMPA)
Intuitive, a global leader in robotic-assisted surgery and minimally invasive care, is seeking a Regulatory Affairs Specialist (NMPA) to join their team. This role is based in Sunnyvale, CA, and involves collaborating with the in-country Regulatory Affairs (RA) team, Product Localization Engineering (PLE), and other cross-functional teams to ensure compliance with China's regulatory requirements throughout the product lifecycle. The position requires a hybrid work schedule, with weekly onsite presence in Sunnyvale.
The Regulatory Affairs Specialist will lead China product registration applications, coordinating regulatory and clinical strategy development, and ensuring deliverables meet NMPA submission standards. Responsibilities include drafting and reviewing sections of regulatory dossiers, managing registration trackers, and maintaining the China Regulatory Project Executive Summary. The role also involves supporting the post-market team with China Periodic Safety Update Reports (PSUR) and assisting in internal and external audits related to China compliance.
Candidates should have a minimum of three years of regulatory affairs experience, with at least one year focused on NMPA medical device regulatory requirements and China GB/YY standards. Experience with new product development projects for complex products is essential. Strong verbal and written communication skills are required, along with the ability to translate technical documentation into effective regulatory submissions. Proficiency in Microsoft Word, Excel, and Project applications is necessary. Mandarin Chinese language skills are required for this position.
The compensation package includes a base salary ranging from $114,800 to $165,200 per year, depending on experience and qualifications. Additional benefits and perks are offered as part of the employment package.
Intuitive fosters a culture of innovation and collaboration, aiming to make surgery smarter, safer, and more human. The company offers opportunities for professional growth and development, encouraging team members to contribute to transforming the future of healthcare.