Senior Regulatory Affairs Specialist

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. 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. Travel Percentage: None #J-18808-Ljbffr