Regulatory Affairs Specialist 3, LATAM

📋 Description

• Support the development and execution of regulatory strategies for new product registrations
• Assist in preparing, compiling, and maintaining regulatory submissions in accordance with
• Contribute to registration planning activities to support timely market access and product
• Conduct and document regulatory assessments for product changes, including evaluation of
• Monitor and evaluate new or revised medical device regulations, standards, guidance documents, and
• Assess the potential impact of regulatory changes on registered products, ongoing projects, and

🎯 Requirements

• Minimum of 5 years of Regulatory Affairs experience within the medical device, healthcare
• Advanced written and verbal communication skills in English and Spanish.
• Demonstrated experience supporting product registrations, amendments, renewals, and regulatory
• Experience conducting and documenting regulatory impact assessments and product change evaluations.
• Strong knowledge of LATAM medical device regulatory frameworks, including regulatory requirements
• Ability to interpret regulations, standards, guidance documents, and technical product