Regulatory Intelligence Specialist

Primary Function of Position

Responsible for the collection coordination and summary of global regulatory intelligence that pertains to the company and our portfolio. Manage internal intelligence communications and act as SME for RI database; collaborate with global partners to coordinate and collect updates from their specific regions.

Essential Job Duties

• Solid understanding of how to analyze regulatory intelligence and translate it into clear implications for product development clinical strategy submissions and lifecycle management.
• Help establish and refine internal regulatory intelligence processes and best practices.
• Evaluate and implement tools databases or systems that enhance regulatory intelligence capabilities.
• Contribute to continuous improvement of Reg Intel processes.
• Develop internal communications training materials and presentations to keep teams informed of relevant intelligence updates.
• Assist RI Leader in building a culture of regulatory awareness across the organization.

Qualifications :

Required Experience and Education

• Minimum 5 years of experience in regulatory affairs and bachelors degree in a relevant discipline or equivalent combination of
• education and experience.
• Demonstrated ability to interpret complex regulatory information and translate it into business impact.

Required Knowledge Skills and Abilities

• Project management abilities.
• Strong written and verbal communication.
• Project coordination and time management skills.
• Strong analytical and problem-solving skills.
• Ability to interpret and translate complex topics into simple language without losing context.
• Competence with document management systems and Microsoft Office.

Preferred Knowledge Skills and Abilities

• Experience supporting innovative technologies such as surgical robotics digital health or complex medical devices.
• Familiarity with global regulatory pathways and evolving regulatory frameworks.

Physical Requirements

• Not applicable

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 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

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 employeeswho 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 governments 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 employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time