Alajuela, CRI
1 day ago
Regulatory Affairs Project Manager
**Regulatory Affairs Project Manager** This responsible for supporting and leading regulatory excellence projects, and continuous improvement initiatives, contributing valuable insights and proposing necessary corrective actions to address any gaps in regulatory compliance processes, working under limited supervision. The role leads the development and utilization of centralized regulatory affairs tools, ensuring compliance with all relevant regulations and standards. The role supports comprehensive evaluations of the organization to assess its current level of regulatory excellence maturity, identifying strengths, weaknesses, and opportunities for improvement. The role guides strategic initiatives towards enhanced performance to further improve regulatory compliance efforts. **Your role:** * Handles projects focused on regulatory compliance and process improvement by applying Lean, 6S, Kaizen, and continuous improvement methodologies to enhance performance and drive organizational change. * Supports comprehensive evaluations of the organization to assess its current level of Regulatory Excellence maturity, using data and analytics to identify strengths, weaknesses, and opportunities for improvement, thereby guiding strategic initiatives towards enhanced performance. * Provides guidance for strategic initiatives towards enhanced performance to further improve regulatory compliance efforts, and reviews the creation or modification of operational infrastructures to support strategic objectives and drive sustainable results. * Facilitates the development and utilization of centralized regulatory affairs tools, ensuring compliance with all relevant regulations and standards. * Provides regulatory expertise in deploying IT tools for Regulatory Information Management (RIM) in alignment with overall regulatory excellence goals. * Perform administrative role for Regulatory Information Management tools. * Maintain compliance of regulatory IT tools through validation, including testing and preparation of validation deliverables. * Maintains and analyzes regulatory data and conducts validation of regulatory affairs software tools. * Guides improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System for regulatory affairs IT tools, including guidance, training, and work instructions. **You're the right fit if:** + You have Bachelor's or Master's Degree in Business Administration, Legal, Communications, Science or equivalent. + You have at least 2 years in the Health Systems area. + You have experience with Regulatory Information Management tool, preferable RIMSYS or other IT tools for Regulatory Information Management (RIM); + Your skills include Continuous Improvement Mindset and project management. + Fluent English; + Administrative role; **How we work together** We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Administrative/office role. **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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