Primary Function of 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, make sure the company's regulatory affairs activities are conducted in accordance with company policies and in compliance with 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.
Essential Job Duties
- With minimum oversight, act as the RA project lead when support China product registration applications. Such role covers the responsibilities of being both 'the RA Lead at ISI side' and 'the RA Project Manager', more specific speaking, responsible for the followings:
- Coordinate and assist in efforts of regulatory/clinical strategy development and timeline establishment.
- With the collaboration with JVRA, 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 the activities pertaining to the Product Technical Requirement (PTR) draft and type testing, including test sample arrangement.
- Responsible for the writing, review of certain sections of the dossier.
- Coordinate and work with JVRA and ISI stakeholders on 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.
- As a member of the China/HK RAQA group, is required to demonstrate flexibility as priorities change.
- Support department goals and continuous improvement initiatives.
- 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 (in back room) in internal and external audits related to China compliance.
- Provide support in China localization projects when needed (manufacturing transfer, etc.)
- Work with post-market team in support of the China Periodic Safety Update Reports (PSUR) generation.
- Provide working-level guidance to contractor for completing the task assigned.
Required Skills and Experience
- Minimum 3 years RA experience is required.
- Demonstrated understanding of NMPA medical device regulatory requirement China GB/YY standards, as well as fundamental US FDA requirements posed on medical device.
- 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 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.
Working Conditions
None
Preferred Skills and Experience
- SaMD and SiMD knowledge a plus.
- Minimum 1 year working experiences supporting international submissions preferred.
- Previous China regulatory affairs experiences a major plus.
- Experience with RIMS (e.g., Veeva, Rimsys, etc.) is a plus.
- Cross-cultural (China) RA project related 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.
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 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.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
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.
