Intuitive
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Regulatory Affairs Technical Lead
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Intuitive 1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by Intuitive. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$146,400.00/yr - $247,800.00/yr Overview
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 values inclusion and diverse perspectives and invests in long-term growth for its team members. Job Function: Engineering and Information Technology; Industries: Medical Equipment Manufacturing. Seniority level: Mid-Senior level; Employment type: Full-time. Workplace type: Onsite with leader-defined events and activities; Shift: Day. Primary Function of Position
This senior individual contributor role in Regulatory Affairs will report to the Director of Regulatory Affairs and perform work for the Multiport da Vinci Surgical System business unit of Intuitive. The role focuses on creating premarket submissions for the US market for the multiport da Vinci 5 Surgical System. There may be additional postmarket sustaining activities or other cross-functional duties related to da Vinci 5 instruments and accessories or other Intuitive products. A total product life cycle (TPLC) model of work is expected. The RA Technical Lead will be part of cross-functional teams bringing new products to market and serve as a subject matter expert and mentor for RA colleagues. Essential Job Duties
Have broad regulatory affairs expertise or unique knowledge to contribute to development of company objectives and principles and achieve goals creatively and effectively. Lead departmental and cross-functional projects and teams. Lead strategic initiatives from concept through completion; contribute to budget, resource, and financial planning; coach and guide colleagues. Address significant and unique issues requiring evaluation of intangibles. Exercise independent judgment in methods and evaluation criteria for obtaining results. Create formal networks involving coordination among groups and consistently communicate across organizational levels. Influence senior stakeholders and lead communication across teams. Work independently to determine methods and procedures on new assignments; may supervise others. Operate with limited supervision and drive results; set priorities. Make decisions and resolve issues impacting multiple teams and departments. Qualifications
Required Skills and Experience
Proven ability to engage with regulatory agencies (e.g., FDA) with minimal supervision. Experience authoring 510(k) submissions and driving through clearance; provide a writing sample (e.g., Correspondent Contact on a cleared 510(k) with FDA Summary). Experience authoring Pre-Submissions and holding meetings with FDA. Experience authoring IDE applications. Ability to review technical documentation for scientific soundness, accuracy, and regulatory compliance. Experience creating risk assessment documentation. Interpret regulations for non-RA professionals; adapt planning and strategy as needed. Ability to influence stakeholders and prioritize patient safety alongside business needs. Proactive problem solver with strong quality system, risk management, and documentation practices. Experience using FDA\'s eSTAR template and electronic submissions portal. Required Education and Training
Typically requires a minimum of 12 years of related experience with a STEM Bachelor’s degree; or minimum 8 years with a Master’s; or PhD with minimum 5 years; or equivalent experience. Working Conditions
Primarily an office environment. May be exposed to tissue, animal, or clinical labs. Preferred Skills and Experience
Regulatory Affairs Professional Certification for Medical Devices (RAC). Experience preparing OUS submissions and experience with robotic surgical systems or devices. Working knowledge of human anatomy, physiology, and soft tissue surgical procedures. Additional Information
Due to the nature of our business and the role, Intuitive and/or your customer(s) may require proof of vaccination against certain diseases including COVID-19. Details vary by role. Intuitive is an Equal Opportunity Employer and prohibits discrimination or harassment of any type. We consider qualified applicants with arrest and conviction records in accordance with fair chance laws. Base Salary Range (Regions)
Region 1: $172,200 - $247,800 Region 2: $146,400 - $210,600 Other
Shift: Day. Workplace Type: Onsite for leader-defined events; frequency may increase based on business need. Locations
Sunnyvale, CA area; other listings shown are not part of this role.
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Regulatory Affairs Technical Lead
role at
Intuitive 1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by Intuitive. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$146,400.00/yr - $247,800.00/yr Overview
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 values inclusion and diverse perspectives and invests in long-term growth for its team members. Job Function: Engineering and Information Technology; Industries: Medical Equipment Manufacturing. Seniority level: Mid-Senior level; Employment type: Full-time. Workplace type: Onsite with leader-defined events and activities; Shift: Day. Primary Function of Position
This senior individual contributor role in Regulatory Affairs will report to the Director of Regulatory Affairs and perform work for the Multiport da Vinci Surgical System business unit of Intuitive. The role focuses on creating premarket submissions for the US market for the multiport da Vinci 5 Surgical System. There may be additional postmarket sustaining activities or other cross-functional duties related to da Vinci 5 instruments and accessories or other Intuitive products. A total product life cycle (TPLC) model of work is expected. The RA Technical Lead will be part of cross-functional teams bringing new products to market and serve as a subject matter expert and mentor for RA colleagues. Essential Job Duties
Have broad regulatory affairs expertise or unique knowledge to contribute to development of company objectives and principles and achieve goals creatively and effectively. Lead departmental and cross-functional projects and teams. Lead strategic initiatives from concept through completion; contribute to budget, resource, and financial planning; coach and guide colleagues. Address significant and unique issues requiring evaluation of intangibles. Exercise independent judgment in methods and evaluation criteria for obtaining results. Create formal networks involving coordination among groups and consistently communicate across organizational levels. Influence senior stakeholders and lead communication across teams. Work independently to determine methods and procedures on new assignments; may supervise others. Operate with limited supervision and drive results; set priorities. Make decisions and resolve issues impacting multiple teams and departments. Qualifications
Required Skills and Experience
Proven ability to engage with regulatory agencies (e.g., FDA) with minimal supervision. Experience authoring 510(k) submissions and driving through clearance; provide a writing sample (e.g., Correspondent Contact on a cleared 510(k) with FDA Summary). Experience authoring Pre-Submissions and holding meetings with FDA. Experience authoring IDE applications. Ability to review technical documentation for scientific soundness, accuracy, and regulatory compliance. Experience creating risk assessment documentation. Interpret regulations for non-RA professionals; adapt planning and strategy as needed. Ability to influence stakeholders and prioritize patient safety alongside business needs. Proactive problem solver with strong quality system, risk management, and documentation practices. Experience using FDA\'s eSTAR template and electronic submissions portal. Required Education and Training
Typically requires a minimum of 12 years of related experience with a STEM Bachelor’s degree; or minimum 8 years with a Master’s; or PhD with minimum 5 years; or equivalent experience. Working Conditions
Primarily an office environment. May be exposed to tissue, animal, or clinical labs. Preferred Skills and Experience
Regulatory Affairs Professional Certification for Medical Devices (RAC). Experience preparing OUS submissions and experience with robotic surgical systems or devices. Working knowledge of human anatomy, physiology, and soft tissue surgical procedures. Additional Information
Due to the nature of our business and the role, Intuitive and/or your customer(s) may require proof of vaccination against certain diseases including COVID-19. Details vary by role. Intuitive is an Equal Opportunity Employer and prohibits discrimination or harassment of any type. We consider qualified applicants with arrest and conviction records in accordance with fair chance laws. Base Salary Range (Regions)
Region 1: $172,200 - $247,800 Region 2: $146,400 - $210,600 Other
Shift: Day. Workplace Type: Onsite for leader-defined events; frequency may increase based on business need. Locations
Sunnyvale, CA area; other listings shown are not part of this role.
#J-18808-Ljbffr