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.

Primary Function of Position

Sr. Business Analyst, Regulatory Affair Business Systems will possess both technical and functional understanding of the Regulatory business process and will be a key person in the implementation of technology solutions that add business value. The role will be responsible for identifying, analyzing, refining, translating, and finally documenting business requirements from ISI business teams. In addition, the role will ensure business requirements are accurately developed and tested through authoring and executing test scripts. This is a business role that will work closely with global business users and IT solution team to ensure business needs and projects are delivered.

Essential Job Duties

• Interface with Regulatory Affairs Business teams to determine technical and functional requirements that support organizational business goals, documenting those requirements, and working with Product Managers, Project Managers and IT to deliver business technology solutions.
• Assists with the review of business case documents, project plans and schedules to ensure business needs are met.
• Facilitate sessions with all relevant stakeholders to drive clarity and agreement on requirements.
• Partner across Regulatory Affairs to translate and evangelize business needs/strategies into solutions that interoperate, create efficiencies, provide the highest level of customer experience, and drive improved utilization of self-service/automation by internal and/or external users.
• Documentation of requirements, authoring & execution of test cases and change management procedures for existing mission critical systems & applications ensuring change meets (or exceeds) business objectives.
• Responsible for execution, and success of complex projects. Collaborate within cross-functional teams to deliver and maintain best-in-class solutions.
• Develops and describes a sufficiently deep and comprehensive understanding of both, the business processes/objectives/outcomes and technology solutions and uses that knowledge to propose and guide business improvements.
• Provides expert consultation for business projects that often integrate new technology and/or carry out organization-wide operational and technology functions.
• Reviews, updates and develops documentation including but not limited to: requirements, process workflows, user stories, use cases, data mapping/validations, business rules, scripts, and procedures for future reference or use.
• Responsible for consistency, clarity, and quality in all documentation and other artifacts by reviewing, validating, editing, rewriting, and authoring as necessary. Performs other duties as assigned.

Required Skills and Experience

• Strong understanding of the Regulatory Affairs business process.
• Experience working with business end-users, gathering requirements, and building detailed user specification requirements.
• Active and successful team lead/participant capable of motivating others within a non-direct reporting structure to execute change.
• Outstanding analytical skills and proven track record of utilizing team-based approach to quickly and accurately resolve system/solution issues.
• Strong knowledge of business information technology best practices.
• Strong business analysis, and project management skills.
• Strong communication and writing skills on a business and technical level.
• Demonstrated skills in solution development and implementation from a business owner perspective.
• Strong skills in documentation for business and technology user audiences.
• Strong technical background and ability to effectively balance multiple priorities.
• Strong understanding of system development, IT and business process and their inter-relationship.
• Demonstrates collaborative and consensus building strengths.
• Proven creative problem solver with ability to work effectively in a hyper-changing environment.
• Able to work independently and consider cross-functional and downstream impacts with close attention to detail.
• Experience with applications built on cloud solutions
• Familiarity with web development frameworks and database management system
• Ensure best practices in code quality, testing, and documentation
• Participate in architectural and design discussions
• Guide stakeholders in adopting industry best practices and change management
• Experience with applications built on cloud solutions
• Familiarity with web development frameworks and database management systems
• Ensure best practices in code quality, testing, and documentation

Required Education and Training 

• Minimum Bachelor's degree in Computer Science, Software Engineering, or a related field
• Minimum of 5-7 years of experience in software development, preferably in SaaS environments and business analysis
• Strong understanding of SaaS architecture and business models
• Proficiency in programming for data analysis and automation
• Experience with latest technologies and their applications in SaaS environments
• Familiarity with querying languages for data querying in Veeva Vault systems
• Excellent communication skills to bridge communication between stakeholders
• Experience in small SaaS product companies or startups
• Knowledge of project management methodologies (e.g., Agile, Scrum)
• Understanding of regulatory processes in the medical device industry

Preferred Skills and Experience

• Certification in relevant cloud technologies or regulatory information management systems
• Familiarity with integration design and implementation planning
• Background in risk analysis and mitigation strategies
• Experience in data migration and data governance

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.