Regulatory Affairs Specialist - (NMPA/CFDA) (Finance)

Company Description
At Intuitive, we are united behind our mission: 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.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world 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 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 advance the world of minimally invasive care.
Job Description
Primary Function of Position

This RA Specialist will play a key role in managing China RA regulatory intelligence, working closely with the in-country RA team to facilitate China regulation and standard assessment. This position will also collaborate with the local RA team, 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 maintain regulatory compliance across all relevant aspects of the product lifecycle for China and Hong Kong. Additional responsibilities include regulatory operation activities to support the Approved Product List (APL) process, and product shipping block (RA Block) and release processes. The RA Specialist will also provide cross-functional support and manage assigned tasks pertaining to pre-market applications and/or post-market regulatory compliances.

Essential Job Duties

• Regulatory Intelligence Coordination
  • Serve as the Point of Contact (PoC) for Regulatory Intelligence, focusing on Regulations and Standards Assessment (RSA) for China RAQA department.
  • Collaborate with the in-country RA team to monitor, maintain, and communicate updates on China Regulations & Standards applicable to ISI products.
  • Work with the ISI RSM team to update standards and regulations in Trackwise, engaging with ISI SMEs for RSA completion and implementation as needed.
  • Conduct gap assessment on China regulatory changes to support strategic decision-making.
  • Maintain a knowledge base of regulatory affairs guidelines in China and Hong Kong, providing input on updated regulations and standards as needed.
• Regulatory submissions and GRA (Global Regulatory Assessment)
  • Coordinate and prepare regulatory filing/submission documents and work with in-country RA team for submissions to regulatory authorities in China & Hong Kong.
  • Provide regulatory guidance on China and Hong Kong regulatory requirements for new product development and product change projects, ensure compliance with submission deliverables.
  • Maintain regulatory clearances and approvals, including necessary filings, archival, and communications.
  • Conduct global regulatory assessment (GRA) for Hong Kong in partnership with the in-country RA team and prepare the associated change notifications and registrations to support supply continuity.
• Regulatory Operations
  • Support the post-market team in preparing the China Periodic Safety Update Reports (PSUR) and annual inspection report.
  • Support the Approved Product List (APL) process.
  • Assist in product shipping block (RA Block) and release processes.
  • Develop and maintain departmental procedures and database, contributing to continuous improvement initiatives as needed.
  • Coordinate recall or market withdrawal activities as needed.

Qualifications
Required Skills and Experience

• Minimum 3 years RA experience is required.
• Demonstrated understanding of NMPA medical device regulatory requirements, China GB/YY standards, Hong Kong MDD regulatory requirements, as well as fundamental US FDA requirements posed on medical device.
• Experience with new product development projects for complex products.
• Proven 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 execute to aggressive goals
• Keen on delivering quality results and introducing best practices.
• Highly proficient in Microsoft Word, Excel, and Project applications

Required Education and Training

• Education: B.S./B.E. or higher in life science, biomedical engineering or related filed.
• Advanced degree preferred.

Preferred Skills and Experience

• Minimum 2 years working experiences supporting international submissions preferred,
• Previous China/Hong Kong regulatory affairs experience a major plus.
• Cross-cultural (China/Hong Kong) RA project related a plus.
• SaMD and SiMD knowledge a plus.
• RAC (regulatory affairs certified) desirable.
• Ability to speak and write in Chinese is a plus.
• Knowledge of SAP, Agile or similar business systems desired.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal 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.

Mandatory Notices

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

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Base Salary Range Region 1: $114,800 USD - $165,200 USD
Base Salary Range Region 2: $97,600 USD - $140,400 USD
Shift: Day
Travel: 10% of the time
Workplace Type: Onsite - This job is fully onsite.