Senior Specialist, Regulatory Information Management & Innovation (RIM&I)
Highly accomplished Regulatory Affairs professional with over 9 years of dedicated experience in managing complex regulatory information systems and processes within the pharmaceutical and medical device industries. Proven expertise in driving data quality, compliance, and innovation in Regulatory Information Management (RIM), including system validation, process optimization, and archival of glob...
Experience: 10+ years
LESLIE T. GRIMES provides regulatory consulting services to clients in:
Holds a Bachelor of Arts in Justice Studies from Montclair State University and an Associate of Arts in Communications from Ocean County College. This academic foundation provides a strong understanding of regulatory frameworks, policy analysis, and effective communication, which are crucial for navigating complex regulatory landscapes in the medical technology industry.
Possesses extensive experience as a Senior Specialist in Regulatory Information Management & Innovation (RIM&I) and Regulatory Affairs System Analyst, contributing to major industry players. Demonstrated expertise in managing and optimizing regulatory information systems, ensuring data quality, and driving compliance with global health authority requirements. Proven ability to support system implementations, process development, and archival of critical regulatory documentation, making them a valuable asset for companies seeking robust regulatory operations.
Highly accomplished Regulatory Affairs professional with over 9 years of dedicated experience in managing complex regulatory information systems and processes within the pharmaceutical and medical device industries. Proven expertise in driving data quality, compliance, and innovation in Regulatory I...
With over 9 years of specialized experience, Leslie T. Grimes is an exceptionally valuable asset for medtech companies navigating the complexities of Regulatory Information Management (RIM) and innovation. Their deep expertise in managing regulatory information systems, ensuring data quality, and driving compliance with global regulatory requirements (FDA, EMA, ICH) is a significant strength. Leslie's proven ability to optimize processes, validate systems, and handle archival of global health authority interactions directly addresses critical operational needs for medtech firms. Their strong analytical skills in system analysis and data migration, coupled with a commitment to data integrity and timely remediation, make them adept at enhancing regulatory workflows and supporting submission readiness, particularly for Software as a Medical Device (SaMD) and cloud-based platforms.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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