RA Specialist 3

Company Description

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.

Job Description

Primary Function of Position
The RA Specialist Level 3 plays a key supporting role within the Regulatory Affairs team, assisting senior specialists (Levels 4 and 5) in the execution of regulatory activities. This position is responsible for contributing to change assessments, gathering and organizing documentation required for product registration submissions, and ensuring compliance with applicable regulatory requirements across LATAM markets.

Essential Job Duties

• Support RA Specialists Level 4 and 5 in conducting regulatory change assessments.
• Collect, review, and organize documentation required for product registration and regulatory submissions.
• Coordinate with internal stakeholders (e.g., R&D, Quality, Supply Chain) to obtain necessary information and ensure timely submission.
• Maintain regulatory databases and trackers to monitor submission status and document control.
• Assist in preparing regulatory dossiers in accordance with local requirements.
• Ensure compliance with internal procedures and applicable regulatory standards.

Qualifications

Required Skills and Experience 

• Minimum 2–4 years of experience in Regulatory Affairs or a related field within the life sciences industry.
• Proven ability to support regulatory change assessments and compile documentation for product registration.
• Strong organizational and time management skills to handle multiple tasks and deadlines.
• Attention to detail and accuracy in document handling and regulatory submissions.
• Effective communication skills to collaborate with cross-functional teams (e.g., Quality, R&D, Supply Chain).
• Familiarity with regulatory requirements in LATAM markets.
• Experience using document management systems and regulatory databases.
• Advanced English proficiency is required for effective communication and documentation.

Required Education and Training

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Chemistry, or a related discipline.
• Training or coursework in Regulatory Affairs or Quality Assurance is preferred.

Working Conditions

• Hybrid work model with a minimum of 2 days per week at the office.
• Occasional meetings across time zones may require schedule flexibility.

Preferred Skills and Experience

• Experience supporting product registration submissions in multiple LATAM countries.
• Knowledge of international regulatory frameworks (e.g., ANVISA, COFEPRIS, INVIMA).
• Familiarity with regulatory software tools (e.g., Veeva Vault, TrackWise).
• Ability to read and interpret technical product documentation.
• Spanish language skills are a plus, especially for communication with local authorities and affiliates

Additional Information

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.