Regulatory Affairs Specialist (NMPA)

Intuitive•Sunnyvale, CA

41d•Hybrid

About The Position

This position will partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams, to ensure the company's regulatory affairs activities are conducted in accordance with company policies and in compliance with the latest relevant regulations and standards. The goal is to ensure regulatory compliance against China requirements for all relevant aspects throughout the lifecycle of the products subject to the China market. Additional responsibilities include maintaining regulatory filings and licenses. This role will provide support to cross-functional teams, responsible for assigned tasks pertaining to pre-market applications and/or post-market regulatory compliances.

Requirements

Hybrid onsite weekly in Sunnyvale, CA or Peachtree Corners, GA
Mandarin Chinese speaking is required for this position
Minimum 3 years RA experience is required.
Minimum 1 year of NMPA medical device regulatory requirement
Knowledge of China GB/YY standards, as well as fundamental US FDA requirements posed on medical devices.
Experience with new product development projects for complex products.
Strong 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 (as a leader or co-leader or project manager) cross-functionally/regionally to support strategy development, drive planning and execution of ambitious goals.
Keen on delivering quality results and introducing best practices.
Highly proficient in Microsoft Word, Excel, and Project applications
Education: B.S./B.E. or higher in life science, biomedical engineering or related field.

Nice To Haves

Advanced degree preferred.
SaMD and SiMD knowledge a plus.
Experience with RIMS (e.g., Veeva, Rimsys, etc.) is a plus.
RAC (regulatory affairs certified) desirable.
Knowledge of SAP, Agile or similar business systems is desired.

Responsibilities

Act as the RA project lead when supporting China product registration applications, covering responsibilities of being both 'the RA Lead at ISI side' and 'the RA Project Manager'.
Coordinate and assist in efforts of regulatory/clinical strategy development and timeline establishment.
Provide explanation to ISI supportive teams on China regulatory requirement to ensure the deliverables prepared for NMPA submission are compliant.
Coordinate and prioritize tasks assigned with oversight.
Support activities pertaining to the Product Technical Requirement (PTR) draft and type testing, including test sample arrangement.
Responsible for the writing and review of certain sections of the dossier.
Coordinate and work with JVRA and ISI stakeholders on providing supportive information required for regulator communications (consultation, workshop, etc.).
Create and maintain the registration tracker to ensure deliverables required for submission or deficiency response are comprehensively captured covering all relevant aspects and updated timely.
Maintain the China Regulatory Project Executive Summary for responsible projects.
Review and approve GRAs.
Articulate local regulatory requirements to the organization as needed.
Assist in developing or revising internal procedures to ensure continuous compliance with all China applicable regulatory requirements.
Support internal and external audits related to China compliance.
Provide support in China localization projects when needed (manufacturing transfer, etc.).
Work with the post-market team in support of the China Periodic Safety Update Reports (PSUR) generation.
Provide working-level guidance to contractors for completing assigned tasks.