Sr. Project Manager, Clinical Affairs

Primary Function of Position

The Senior Project Manager, Clinical Affairs, plays a pivotal role in supporting Clinical Affairs activities by partnering with key functions and business units across the organization, including R&D, Regulatory Affairs (RA), Clinical Development Engineering, Quality, and Business Unit PMOs. This role brings disciplined structure, cross-functional coordination, and strategic oversight to high-priority clinical affairs initiatives.

Responsibilities

• Lead project planning, initiation of Clinical Affairs activities across clinical studies and clinical dossier deliverables, ensuring alignment to program milestones and regulatory expectations.
• Develop and maintain integrated project plans that define scope, timelines, dependencies, resourcing, and deliverables for key Clinical Affairs workstreams.
• Partner with cross-functional teams (R&D, Regulatory, Business Units, Clinical Development Engineering, Quality, and PMO) to align dependencies to support Clinical Affairs deliverables to the broader product development lifecycle.
• Track progress against milestones for clinical trials and global clinical dossier submissions (e.g., EU Clinical Evaluation Reports [CERs]), including metric reporting and portfolio status summaries.
• Facilitate routine cross-functional meetings; provide clear status updates, document decisions, and capture/drive action items to closure.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum of 5 years’ experience in clinical project management, with at least 3 years focused on medical device development.
• Experience acting as a liaison between clinical and technical/project management teams.
• Knowledgeable with all stages of clinical studies, design control process, product development lifecycle; including idea generation, concept development and testing, design, implementation, validation and transfer.
• Project Management: Advanced organizational, planning, and prioritization skills; proficiency with project management tools such as Smartsheet, MS Project, or equivalent and methodologies.
• Regulatory Acumen: Strong understanding of clinical research regulations and standards applicable to medical devices. Familiarity with global regulatory requirements (e.g., FDA, EU MDR, ISO 14155, ICH GCP).
• Certification in project management (PMP) desired.

Nice to Have Skills

• Proven track record of successful cross-functional project leadership in a regulated environment.
• Leadership: Ability to inspire, influence, and drive teams toward common goals.
• Communication: Excellent written and verbal communication skills; adept at presenting complex information to diverse audiences.
• Problem Solving: Proactive in identifying issues and developing effective solutions.
• Collaboration: Experience working with multidisciplinary teams and external partners.
• Attention to Detail: Commitment to accuracy and quality in all deliverables.

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.
• 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 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.
• 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. 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. Base Salary Range Region 1: $150,500 - $216,500 Base Salary Range Region 2: $127,900 - $184,000
• Shift: Day
• Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.