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:

The Senior Project Manager, Regulatory Business Systems will work closely with  Regulatory, Product Quality, Compliance, and IT organizations This Senior Project Manager role will manage quality and regulatory business system projects ensuring the product vision, priorities, and solutions are actively serving the functional and cross functional business needs. Primary responsibilities include project management for process and systems maintenance and improvements as well as sustaining support for Quality and Regulatory Business System needs. This role will take responsibility for the delivery of the project deadlines and commitments.

 

This is a business role and not an solution (IT) role.

 

Roles and Responsibilities:

  • Lead and organize project teams to drive focused results and projects related to
    • Regulatory, Compliance, Quality and related business processes and systems
    • Process and business requirement mapping to business systems
    • Operating business model analysis and action plan identifications
    • Alignment with quality management systems (QMS) requirements
    • Standardization of documentation and templates
    • Cross functional process improvements
    • Change management for processes and systems
    • Support growth model strategy to support future state
    • Expand value streams for IT landscape across organization
  • Align with IT Project Managers on systems strategy, schedule, scope and deliverables.
  • Provide input, guidance, training and mentoring related to Regulatory, Quality, Compliance, and related cross functional teams specific to the regulatory business system strategy and mission
  • Accomplish project objectives by planning and evaluating project related activities and communicating status and project to management on a regular basis
  • Contribute information and recommendations to strategic plans
  • Prepare and complete action plans to implement productivity, quality, problem resolving, identifying trends, determine system improvements, and implement change
  • Enhance department and organization reputation by accomplishing requests, exploring opportunities and adding value to job accomplishments
  • Develop tools and best practices
  • Lead task teams for cross functional projects
  • Establish, prepare, analyze and metrics
  • Develop relevant procedures in support of continuous improvement in the Quality Management System
  • Participate as the Business Architecture representative on other projects as requested or needed
Qualifications

Skill/Job Requirements

  • Education:
    • Bachelors degree or associates with equivalent work experience.
    • Non-technical degree with equivalent complex medical device experience acceptable
  • Experience/Skills:
    • Minimum 10+ years relevant experience working in project / program management required
    • Previous experience in medical device, life sciences, or pharmaceuticals strongly preferred
    • Experience working with business systems especially electronic quality management systems or regulatory information management strongly preferred
    • PMP certification strongly preferred
    • Excellent stakeholder management required
    • Excellent conflict resolution skills and ability to motivate a project team required
    • Experience with Smartsheet, MS Project, or similar project management software required
    • Strong verbal and written communication skills, proven ability to translate analytical information into effective presentations required
    • Solid attention to detail, organization skills, and extensive ability to multi-task across multiple projects/activities in a team setting required

 

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.

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.

Shift : Day

Travel : 10% of the time

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Senior Project Manager, Regulatory Business Systems