Sr. Regulatory Affairs Specialist (remote)

Primary Function of Position

The Sr. Regulatory Affairs Specialist Level 4 is an experienced professional responsible for leading strategic and operational regulatory activities across LATAM markets, with primary focus on Mexico. This role ensures regulatory compliance, manages product registrations and lifecycle activities, and serves as a technical reference for internal teams and regulatory authorities. The specialist influences strategic decisions, anticipates regulatory risks, and aligns business objectives with regulatory requirements.

Essential Job Duties

Regulatory Submissions & Filings

• Lead preparation, submission, and follow-up of regulatory dossiers for complex and critical products in Mexico and LATAM.
• Represent regulatory requirements in meetings with R&D, Quality, Clinical, and executive leadership.
• Develop submission strategies and manage interactions with health authorities, including formal meetings and pre-submission consultations.

Negotiation & Authority Engagement

• Define and execute negotiation strategies with regulatory authorities to resolve complex issues.
• Align internal stakeholders prior to critical regulatory interactions.
• Provide guidance to peers on best practices for regulatory negotiations.

Market & Regulatory Strategy

• Integrate regulatory intelligence into product and portfolio strategies, ensuring alignment with business objectives.
• Anticipate regulatory trends and propose innovative solutions for market access.
• Communicate strategic risks and opportunities to senior leadership.

Lifecycle & Change Management

• Approve and execute regulatory impact assessments for significant product and process changes.
• Develop global strategies for change submissions and ensure ongoing compliance.
• Lead cross-functional decision-making related to regulatory changes.

Leadership & Collaboration

• Act as a technical reference and coach for team members, promoting consistency and regulatory excellence.
• Facilitate alignment across functional areas and influence strategic decisions.
• Model persuasive communication and constructive conflict management.

Required Skills and Experience

• Minimum of 8 years of experience in Regulatory Affairs (LATAM preferred).
• Proven experience with medical device registrations in Mexico and other LATAM countries.
• Deep knowledge of LATAM regulations, ISO standards, and international frameworks (FDA, MDR).
• Strong negotiation, communication, and influence skills in cross-functional environments.
• Advanced English proficiency for documentation and international communication.

Required Education and Training

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biomedical Engineering, or related field.
• Formal training or certification in Regulatory Affairs (RAPS RAC preferred).

Working Conditions

• Hybrid or remote work model, with flexibility for virtual meetings across multiple time zones.

Preferred Skills and Experience

• Experience with regulatory tools (e.g., Veeva Vault, TrackWise).
• Participation in audits and regulatory inspections.
• Familiarity with global submission and negotiation strategies.

Behavioral Competencies

Communication

• Synthesizes and frames complex information for diverse audiences.
• Anticipates concerns and addresses proactively.

Collaboration & Influence

• Builds strong cross-functional relationships and drives alignment.
• Manages conflicts constructively and models inclusive decision-making.

Leadership

• Anticipates regulatory/environmental changes and translates them into opportunities.
• Shapes divisional strategies through collaboration and influence.

Negotiation

• Leads negotiation strategies for projects with regulatory bodies.
• Resolves issues through structured engagement and advises management on negotiation posture.

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.

Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.