New · posted Nov 6
Intuitive · Medical Devices
Senior Manager, Clinical Affairs
- Sunnyvale, CA
- On-site
- Full-time
- Manager
The role
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide.
Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life.
The Future Forward organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery.
If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.
Primary Function of Position
As a Senior Manager of Clinical Affairs, this role is responsible for contributing to clinical strategies and overseeing study execution for emerging technologies across various specialties. Clinical trials in this portfolio may be both in the US and global and include first-human-use and pivotal clinical trials targeted for regulatory submission. This role will oversee and manages clinical protocols and other key study documents in support of regulatory submissions; manage clinical publications and evidence dissemination strategy, oversee manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage team to interface and support all clinical requirements of the company with the applicable guidelines and regulations; foresee challenges and develops critical concepts and methodologies to overcome those. As a functional manager, this role will also lead a team of clinical operations personnel, such as clinical study managers and clinical research associates and play a key role in their development.
As a key cross-functional constituent, this employee will work closely with functions across the organization – Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Research Engineering (CRE), Clinical Research Managers, Global Access Value Economics (GAVE), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies to meet business objectives.
What you need
Skill/Job Requirements
- Minimum Education: Bachelor’s or Master’s degree in scientific field/MD/ PhD with 12+ years of professional experience and at least 3-5 years of supervisory experience is preferred
- Minimum of 5 years of experience independently managing clinical studies through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis and study report, and closeout)
- Excellent clinical operation and project management skills, with strong experience collaborating or leading a cross-functional team
- Proven track record of strong cross-functional and key opinion leader management
- Strong experience with clinical study resources and budget management
- Strong experience supporting development of scientific and regulatory strategies for clinical studies
- Strong experience in developing study protocol and other study documents, conducting literature review, writing clinical section for regulatory submission
- Strong knowledge of 21 CFR part 812 , Good Clinical Practice, ISO14155 and other regulations/guidelines.
- Basic understanding of statistics, statistical methods, and design of experiment
- Previous experience supporting internal and external audit on clinical studies is preferred
- Excellent ability to interact with physicians and other professionals inside and outside the company
- Comfortable in a hospital environment, with experience working with nurses and surgeons; existing or previous experience/familiarity with surgery/surgical technology is preferred
- Strong communication, presentation and interpersonal skills with high attention to detail and organization
- Results-driven attitude and strong problem solving skills, consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
- Must be able to travel up to 30-40%
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.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
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.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
Accommodation & Accessibility Notice:
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 compensation ranges are listed.
What you'll do
Roles and Responsibilities
- Play a key role in the development of company’s strategy for clinical studies to meet business goals and objectives. Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives
- Acting as a key strategic partner to Regulatory Affairs to support regulatory approval of new products and contribute to clinical sections of regulatory submissions
- Responsible for managing resource and study budget to ensure clinical studies are conducted on schedule and within budget while ensuring high quality and compliance
- Build strong and sustaining relationship with investigational sites and investigators for ongoing and future studies
- Work closely with data management to provide guidance on development of case report form (CRF), data cleaning to ensure collection of high-quality data
- Work closely with Biostats in study design, developing statistical analysis plan (SAP), analysis, interpretation and synthesis to develop Clinical Study Report and /or support development of scientific publications
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines) and responsible for ongoing review of departmental procedures and process improvement initiatives
- Responsible for setting up effective goals that are meaningful to the department and impactful to the organization
- Provide functional manager leadership to direct reports and provide ongoing guidance for the assigned team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives
- Sets and hold individual and team accountable for high standard of competencies and overall performance
- Effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant progress
- Develop talents, build a highly capable and effective team of clinical study managers (CSM) and clinical research associates (CRA) to efficiently manage clinical studies
Pay and benefits
Intuitive didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Equity
Incentives
Where you'll work
Sunnyvale, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Sunnyvale, CAEqual opportunity, accessibility and legal noticesIntuitive's statements, word for word
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.
Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [email protected].
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
Manager roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $149,000 | $149,000 | $172,250 |
Comparisons: the base pay employers published on open Clinical Affairs roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Affairs
The general path across 24 open Clinical Affairs roles on Regulatory Jobs, with the titles they carry most. Not Intuitive's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 44 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Clinical trial conduct12
- Documentation and SOPs9
- GMP and compliance7
- Regulatory submissions4
- Data and digital systems3
- Lab testing and methods2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Affairs work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devicesNamed in the posting
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devicesNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
From Regulatory News
Company hiring pulse
Intuitive on Regulatory Jobs
- 34
- Open roles
- 34
- Distinct roles
- 5
- Locations
By discipline
- Quality15 42%
- Regulatory12 33%
- Clinical9 25%
By level
- Senior & Principal22 61%
- Manager8 22%
- Associate & Specialist6 17%
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Senior Manager, Clinical Affairs at Intuitive
Open until filled.