Sr. Regulatory Affairs Specialist

3 weeks ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

Primary Function of Position:

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.

Roles and 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. Provide explanations to ISI supportive teams, in coordination with in-country RA, regarding China regulatory requirements to ensure submission deliverables are compliant.
  • 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).
  • Develop and maintain departmental procedures and database for regulatory affairs, supporting continuous improvement initiatives.
  • Participate in clinical evaluation study as needed.
  • Support the Approved Product List (APL) process.
  • Support post-market regulatory compliance activities, including PSURs (Periodic Safety Update Reports).
  • 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 accordingly.
  • Contribute to departmental goals and perform other duties as required.

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