Regulatory Affairs Specialist 3, LATAM

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.