Senior Regulatory Affairs Specialist NOLA

hace 1 semana

Bogotá, Colombia PowerToFly A tiempo completo

What you will do This role develops and applies intermediate knowledge of Regulatory Affairs (RA) frameworks, legislative requirements, processes, and procedures within the Latin America (LATAM) distribution organization, supporting local, regional, and global Regulatory Affairs and Quality Assurance (RAQA) activities. Execute RA activities in line with defined procedures and processes, customized according to RA pillars and country-specific responsibilities. Collect, organize, and maintain local, regional, and global RAQA intelligence files, supporting data collection for reporting on performance, risks, and issues to local leadership teams. Identify the need for new regulatory procedures and Standard Operating Procedures (SOPs), and participate in their development, implementation, and continuous improvement across RA activities. Perform against established RA targets, Key Performance Indicators (KPIs), and objectives, suggesting opportunities for continuous improvement and supporting their execution. Provide support to LATAM and country RA teams, acting as a subject matter expert to the local business and liaising with manufacturing and Design divisions to ensure adequate RAQA and commercial support. Support the development and local deployment of new systems and procedures, including the integration of new acquisitions and RAQA systems within the local office. Support recruiting, selection, onboarding, and development of talent within the local office to increase performance. Identify training needs, deliver training at any organizational level, and update and develop training materials within the relevant knowledge domain. What you will need Required: Bachelor of Science (BSc) degree in a relevant field. At least 4 years of professional experience in Regulatory Affairs (RA) and/or Regulatory Affairs and Quality Assurance (RAQA). Demonstrated knowledge and application of medical device regulatory requirements, including Medical Device Directive (MDD), European Union Medical Device Regulation (EU MDR), Quality System requirements, and Post-Market Surveillance requirements. Technical knowledge of medical device regulatory and quality requirements. Proficiency in Information Technology (IT) tools, including Microsoft Office. Fluency in English. Preferred: Advanced degree in a relevant field. Regulatory Affairs Certification (RAC). Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. #J-18808-Ljbffr

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