Work Flexibility: Hybrid 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. - In-depth knowledge of regulatory requirements for medical devices, including the Medical Device Directive, EU Medical Device Regulations, Quality Systems, and Post Market Surveillance. - Experience in facilitating meetings with regulatory agencies, conducting internal and external audits, and preparing necessary briefings and documentation. Travel Percentage: 0% #J-18808-Ljbffr