27 days old

Sr. Manager China HK Regulatory

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
    INSUUS211328EXTERNALENUS
At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges.

We believe a great idea can come from anywhere-inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's help to advance the world of minimally invasive care.

Primary Function of Position:

Partner with China JVRA as well as the 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. Drive the regulatory strategy & planning for a variety of product offerings in alignment with regional marketing and global business plans. Lead and contribute to submissions ensuring timely approval of product registrations in China for both initial and change/extension registration applications.

Roles and Responsibilities:

  • Act as the RA Project Lead when support China product registrations and other regulatory filings (e.g., green channel, priority review, etc.). Such Lead role covers the responsibilities of being both 'the RA Lead at ISI side' and 'the RA Project Manager', responsible for the followings:
      • Support regulatory/clinical strategy development and timeline establishment.
      • With the alignment with JVRA, provide explanation to ISI supportive teams on China regulatory requirement to ensure the deliverables prepared for NMPA submission are compliant.
      • Set working level cross- ISI/JV & functional team for submission project, coordinate and prioritize tasks with oversight.
      • Support the activities pertaining to the PTR draft and type testing.
      • Responsible for the writing, review of certain sections of the dossier.
      • Work with JVRA and ISI stakeholders on strategizing, providing supportive information that are required for regulator communications (consultation, workshop, etc.).
      • Create and maintain the Tracker to ensure the deliverables required for submission or deficiency response are comprehensively captured covering all relevant aspects and updated timely when progress is made.
      • Manage the maintenance the China Regulatory Project Executive Summary for the responsible projects.
  • Provide leadership and direction to a small team of US based China/HK regulatory specialists
  • Develop a strong internal team through coaching, stretch assignments and other training opportunities
  • Demonstrate flexibility as team priorities change and support team to update project plans accordingly.
  • Support department goals and continuous improvement initiatives.
  • Review and approve GRAs
  • Engagement with regulators for submission plans and input on draft regulations/guidelines
  • Leverage US/EU experiences, partner with IntuFosun stakeholders (RAQA, Government Affairs) in lobbying and shaping the regulatory requirements related to current and future products
  • Interpret new China medical device regulations with oversight and support developing or revising internal procedures to ensure continuous compliance with all China applicable regulatory requirements.
  • Be involved and act as RA advisor in process improvement projects.
  • Support in internal and external audits related to China compliance.
  • Provide support in China localization projects (manufacturing transfer, etc.)
  • Work with post-market team in support of the China PSUR generation.
  • Train and guide junior RA staff or contractor for completing the tasks assigned to the team.

Skills/Job Requirements:
  • Minimum Education: Bachelor degree in life science, biomedical engineering or related filed. Advanced degree preferred. Software knowledge a plus.
  • Minimum 10+ years Regulatory Affairs experiences in Medical Device Company; Minimum 2 years working experiences supporting international submissions preferred; Previous China regulatory affairs experiences a major plus.
  • Demonstrated understanding of NMPA medical device regulatory requirement (at minimum, Decree 680 along with its lower-level regulations, CMDE guidance documents pertaining to product registration matters, etc.), China GB/YY standards, as well as fundamental US FDA requirements posed on medical device.
  • Demonstrated ability to negotiate alignment cross-functionally on goals and project deliverables
  • Equipped by 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 execute to aggressive goals; Cross-cultural (China) RA project related a plus.
  • Excellent analytical and strategic thinking skills - Able to analyze the evolving priorities of the business and integrate these insights into the sound strategy for his/her own area.
  • Excellent written and verbal communication skills a must
  • Detail oriented, well organized, logic ability
  • Collaboration and Influencing: Has ability to use formal and informal structure, dynamics, and culture of an organization to get things done. Self-confident in defending own position, while highly capable of aligning objectives with that of the overall organization.
  • Keen on delivering quality results and introducing best practices.
  • Mandarin speaking a major plus.
  • Highly proficient in Microsoft Word, Excel, and Project applications
  • Knowledge of SAP, Agile or similar business systems desired.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Shift : Shift 1 - Day

Travel : Yes, 10 % of the Time





Posted: 2021-04-17 Expires: 2021-05-16
Sponsored by:
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Sr. Manager China HK Regulatory

Intuitive Surgical, Inc.
Sunnyvale, CA 94086

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