Manager Regulatory Business Systems

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 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.

Manager Regulatory Business Systems, partners with Regulatory business process owners and SMEs to identify business capability needs, opportunities for efficiency through automation and deliver technology solutions that enhance overall productivity or simplify processes. Ideal candidate has experience championing technology needs of Regulatory function with IT and other technical teams, will bring a combination of strategic understanding, both business and technology experience, have exceptional relationship building skills, expertise in standing up and sustaining compliant, holistic, and scalable enterprise Regulatory business systems. Along with people management responsibilities, this role contributes directly to projects and initiatives by shaping business systems projects, overseeing the implementation, and maintenance of RIM (Regulatory Information Management system) and other business capability solutions for Regulatory. This individual will be able to understand the current complexities of the organization’s Regulatory processes and how those processes flow through current technology and help build future-state business process models to best realize the organization’s growth strategy.

Roles and Responsibilities

• Develop, realize, and sustain Regulatory business system roadmap aligned to strategic priorities and tactical needs of Regulatory function.

• Requirements Elicitation & Gathering, Project Planning and Project Management
  Data Analysis, Data Governance, Data Management, Business Process, Workflow Analysis,
  Functional specifications, Research and Technical analysis

• Partner with Regulatory Process owners and SMEs to understand current and future business initiatives, identify business capability needs, deploy technology solutions that meet compliance needs and enhance productivity.

• Establish and maintain a strategic relationship with appropriate level key stakeholders across organization, drive business systems team’s vision forward and demonstrate value proposition.  

• Lead Regulatory business systems team while maintaining a hands-on approach to work. Bring subject matter expertise to the design and implementation of business system solutions, collaborate cross functionally to discover the root cause of identified issues and develop simple solutions to complex problems.
• Develop deliverables that are valuable to the business, including business capability mapping, 3–5-year business systems roadmaps, business requirements documents, process mapping, and business capability mapping.
• Facilitate project/demand shaping, blueprint outcomes and lead multiple improvement efforts keeping a service and customer focused mentality.
• Provide insights to and gain buy-in from key internal stakeholders including but not limited to Regulatory, Quality, Manufacturing Operations, Engineering, Supply Chain, and Product Development.
• Partner with IT, Business Applications, Enterprise Analytics and system integrators/vendors to ensure technology investments align with business capability needs.
• Drive continuous improvement to enhance overall business performance and customer satisfaction by partnering with IT and other global stakeholders, implementing new business system solutions, and supporting future-growth initiatives.
• Create synergies with global business entities to ensure alignment for needs and growth requirements are met.

Skill/Job Requirements

• Education:
  • B.S. or higher in Science, Technology, Engineering, or related field preferred 
• Experience/Skills:
  • 12+ years of overall industry experience with minimum 7+ years of demonstrated expertise implementing or administration of a RIM (Regulatory Information Management system) and Quality or other regulated business systems.
  • Minimum 5+ years of people leadership experience.
  • Prior experience of implementing enterprise Regulatory business systems like RIM is highly preferred
  • Experience working with business software systems, writing product requirements, process mapping, Strong Project Management Experience required. Experience building multi-year improvement roadmaps.
  • Proven track record of developing people and growing a department.
  • Capable of big picture thinking but also skilled at task-oriented execution. Ability to synthesize data and observations to see trends.
  • Strong verbal and written communication skills, proven ability to translate analytical and technical information into effective presentations for business consumption.
  • Ability to comprehend and communicate complex business / technical challenges in a simplified manner.
  • Independent thinker, willing to present alternative conclusions or inferences.
  • Ability to influence and break down silos within an organization as well across organizations.
  • Experience in continuous improvement methodologies such as Lean Six Sigma preferred.
  • Exceptional ability to lead change using positive and collaborative methods.
  • Experience working in a highly matrixed organization and overcoming ambiguity.
  • Solid attention to detail, organization skills and extensive ability to multi-task and project manage across multiple projects/activities in a team setting.

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 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.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

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.

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 salary ranges are listed.