Labeling Project Manager, Medical Devices

Regulatory Jobs

San Francisco (CA)

On-site

USD 120,000 - 180,000

Full time

7 days ago
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Job summary

Intuitive Surgical is seeking a labeling program manager to lead cross‑functional projects for complex medical devices. You will plan, track, and drive labeling work across product lines and geographies to meet regulatory requirements and business goals.

Applicants should have a strong engineering background, 5+ years in medical devices, and experience with global regulatory environments, reporting, and process improvements. Hybrid or on-site work with travel as needed.

Qualifications

  • Minimum four-year Engineering degree (bachelor’s degree or equivalent) preferred; business or related field may be considered commensurate to work experience.
  • Minimum 5 years professional history working in a medical device industry or equivalent experiences.
  • Experience working in a structured global business environment with multiple disciplines such as Regulatory, Manufacturing, Quality, Information Technology, and Logistics.

Responsibilities

  • Develop, communicate, and implement project plans; monitor progress and performance against the plan; resolve problems, mitigate risk, and minimize delays.
  • Identify scope, develop timeline, and align resources for labeling projects across multiple product lines and geographies to meet objectives.
  • Review labeling updates for labeling content and accuracy to confirm alignment with regulatory requirements.
  • Estimate costs, resources, and durations required to complete projects and tasks.
  • Monitor activities, allocate resources, and assign tasks to ensure goals are met.
  • Liaise with other areas in the organization to secure specialized resources and contributions for projects.
  • Conduct project meetings and prepare reports to communicate the status of the project within and beyond the project team.
  • Work through complex scenarios with project staff to assist and/or benchmark strategies to solve problems.
  • Analyze and evaluate tools and processes; propose and implement accuracy and efficiency improvements.
  • Foster continuous improvement by initiating and managing process improvement projects employing Six Sigma principles and/or Agile project management methodologies.
  • Manage highly complex label content for Intuitive’s diverse products (systems /capital equipment, software, instruments, and accessories).
  • Interact with external and internal teams to drive labeling-related items and tasks to closure.

Skills

Project management
Regulatory labeling
Cross-functional collaboration
Planning & scheduling
Risk management

Education

Bachelor's degree in Engineering
Or related field

Tools

Tableau
Smartsheet
SAP
Microsoft 365
Agile

Job description

Intuitive Surgical is seeking a labeling program manager to lead cross‑functional projects for complex medical devices. You will plan, track, and drive labeling work across product lines and geographies to meet regulatory requirements and business goals.

Applicants should have a strong engineering background, 5+ years in medical devices, and experience with global regulatory environments, reporting, and process improvements. Hybrid or on-site work with travel as needed.

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