Regulatory Affairs Specialist 3

Job Description

Primary Function of Position

The Regulatory Affairs Specialist 3 is responsible for supporting the planning, execution, and maintenance of regulatory activities across Latin America, with a focus on strategic LATAM markets.

This role contributes to the assessment and implementation of product changes, evaluates regulatory impacts and compliance requirements, and supports product registration and lifecycle management activities.

The position monitors evolving regulatory requirements, analyzes their impact on business operations and product portfolios, and helps drive appropriate compliance actions.

Working with moderate independence, the Regulatory Affairs Specialist 3 collaborates closely with cross-functional stakeholders and escalates complex, high-risk, or strategic regulatory matters to senior Regulatory Affairs leadership as appropriate.

Essential Job Duties 

Regulatory Strategy & Registration Management

• Support the development and execution of regulatory strategies for new product registrations, license renewals, and post-approval product changes across LATAM markets.
• Assist in preparing, compiling, and maintaining regulatory submissions in accordance with country-specific regulatory requirements and business objectives.
• Contribute to registration planning activities to support timely market access and product lifecycle management.

Regulatory Assessments

• Conduct and document regulatory assessments for product changes, including evaluation of country-specific regulatory impacts, submission requirements, implementation activities and timelines.
• Monitor and evaluate new or revised medical device regulations, standards, guidance documents, and regulatory expectations across LATAM markets.                                                                                                                          
• Assess the potential impact of regulatory changes on registered products, ongoing projects, and business operations, and support implementation of compliance actions.

Submission Preparation & Health Authority Interactions

• Prepare and coordinate product registration dossiers, change notifications, renewals, and responses to health authority inquiries in accordance with local regulatory requirements.
• Support interactions with health authorities, local regulatory representatives, distributors, and external partners to facilitate successful regulatory outcomes.
• Ensure regulatory documentation is complete, accurate, and maintained in compliance with applicable quality and regulatory requirements.

Cross-Functional Collaboration

• Collaborate with internal cross-functional teams including Quality, R&D, Manufacturing, Supply Chain, Marketing, and Commercial teams to support regulatory initiatives.
• Coordinate with distributors, consultants, and local regulatory partners to obtain documentation and information required to support regulatory activities within established timelines.
• Participate in cross-functional projects and support the resolution of assigned regulatory issues and compliance challenges.

Process and Documentation Management

• Maintain regulatory databases, submission trackers, registration records, and supporting documentation.
• Ensure all assigned activities are conducted in accordance with internal procedures, quality system requirements, and applicable regional regulations.
• Proactively identify regulatory risks, compliance concerns, or process improvement opportunities, escalating issues as appropriate.

Qualifications

Required Skills and Experience 

• Minimum of 5 years of Regulatory Affairs experience within the medical device, healthcare, pharmaceutical, or life sciences industry.
• Advanced written and verbal communication skills in English and Spanish.
• Demonstrated experience supporting product registrations, amendments, renewals, and regulatory maintenance activities across multiple LATAM countries.
• Experience conducting and documenting regulatory impact assessments and product change evaluations.
• Strong knowledge of LATAM medical device regulatory frameworks, including regulatory requirements established by agencies such as ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), and other regional authorities.
• Ability to interpret regulations, standards, guidance documents, and technical product documentation, and determine appropriate regulatory pathways and compliance actions.
• Strong analytical, critical thinking, and problem-solving capabilities, with the ability to assess risks, exercise sound judgment, and identify when escalation is warranted.
• Excellent organizational and project management skills, with the ability to manage multiple priorities in a dynamic and fast-paced environment.
• Strong attention to detail and commitment to accuracy in regulatory documentation and submissions.
• Effective communication, influencing, and collaboration skills, with demonstrated ability to work across cross-functional teams and external stakeholders.
• Experience working with document management systems, regulatory information management systems, and electronic quality systems.

Required Education and Training 

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Chemistry, or a related field.
• Additional training or certification in Regulatory Affairs or medical device regulations is preferred.

Working Conditions 

• Hybrid work arrangement with a minimum of two days per week in the office.
• Collaboration with global and regional teams may require participation in meetings across multiple time zones.
• No specific physical requirements are associated with this position.

Preferred Skills and Experience 

• Experience working on medical device registrations across multiple LATAM countries.
• Experience using regulatory and document management systems, such as Veeva Vault, TrackWise, and Agile.

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.

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 employees
who 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 government’s 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 employee’s
start 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. 

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.