- 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.
- Education: Minimum B.S/B.E or higher in life science, biomedical engineering, or related field. Advanced degree preferred. Software knowledge is a plus.
- Minimum 6 years RA experience is required. Minimum 4 years of working experience supporting international submissions preferred; Previous China regulatory affairs experience is a major plus.
- 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.
- Experience with RIMS (e.g., Veeva, Rimsys, etc.) is a plus.
- Excellent 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 time sensitive goals; Cross-cultural (China) RA project related a plus.
- Keen on delivering quality results and introducing best practices.
- RAC (regulatory affairs certified) desirable.
- Ability to speak and write in Chinese is a plus.
- Highly proficient in Microsoft Word, Excel, and Project applications
- Knowledge of SAP, Agile or similar business systems desired.
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Sr. Regulatory Affairs Specialist - Sunnyvale, United States - Intuitive
Description
Company DescriptionAt 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:
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:
Skills/Job Requirements:
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.
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.
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.
