LESLIE T. GRIMES
Expert in Regulatory Information Management (RIM) & Innovation | FDA/Global Compliance | System Analysis & Optimization
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 global health authority interactions. Adept at collaborating with cross-functional teams and external partners to ensure adherence to global regulatory requirements (FDA, EMA, ICH) and support submission readiness. Possesses strong analytical skills for system analysis, data migration, and enhancing regulatory workflows. Committed to ensuring data integrity and timely remediation to support business objectives and regulatory compliance.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment
Pathways Supported:
PMA
Device Types Supported:
SaMD, Medical device
Years Experience:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
other
Technology Types:
samd, cloud_platform
Accepting New Clients:
No
