What you will do

• Execute regulatory affairs (RA) activities in accordance with defined procedures and processes.

• Collect, organize, and maintain files on local, regional, and global RAQA intelligence.

• Identify the need for new regulatory procedures and SOPs, participating in their development and implementation.

• Suggest and support continuous improvement initiatives across RA processes.

• Achieve established targets, KPIs, and objectives for RA activities.

• Provide support to LATAM/country RA teams and assist local RAQA leaders with data collection for performance, risks, and issues reporting.

• Act as a subject matter expert for the local business, supporting the development and deployment of systems and procedures.

• Facilitate the integration of new acquisitions, ensuring RAQA system integration, and support talent recruitment, onboarding, and development at the local office.

What you will need

• Hold a BSc degree in a relevant field; an advanced degree is preferred, and RAC certification is also advantageous.

• 4+ years of experience in regulatory affairs.

• Conversational level in English.

• Demonstrated skills in project and time management, with proficiency in writing, coordinating, and executing complex RA tasks.

• In-depth knowledge of regulatory requirements for medical devices, including the Medical Device Directive, EU Medical Device Regulations, Quality Systems, and Post Market Surveillance.

• Proven ability to influence across the organization and lead technical and scientific RA activities independently.

• Experience in facilitating meetings with regulatory agencies, conducting internal and external audits, and preparing necessary briefings and documentation.