LESLIE T. GRIMES

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.

### **Additional information**

- **Type:** independent
- **Years of experience:** 10
- **Regions served:** US, EU
- **Client types:** large_medtech
- **Location:** United States (New York)
- **Availability:** available_now

---

### **Cruxi analysis**

- **Strength summary:** 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.
- **Unique value:** Leslie T. Grimes offers a unique blend of deep expertise in Regulatory Information Management (RIM) and a strong understanding of innovation within the medtech regulatory landscape. Their proven ability to manage complex regulatory information systems, ensure data integrity, and facilitate global compliance makes them a critical partner for companies prioritizing robust and efficient regulatory operations.
- **Ideal projects:** This consultant is ideally suited for medtech companies, especially those developing Software as a Medical Device (SaMD) or leveraging cloud platforms, who are preparing for or managing submissions through 510(k), PMA, or post-market phases. They are particularly valuable for mid-to-large medtech organizations seeking to optimize their Regulatory Information Management (RIM) systems, improve data quality, or ensure robust compliance processes are in place. Engage Leslie when establishing or enhancing QMS, requiring support for post-market activities, or preparing for FDA mock audits, especially when dealing with international regulatory requirements across the US and EU. Their expertise is crucial for companies aiming for streamlined regulatory operations and efficient submission readiness.
- **Last analyzed:** Tue Dec 23 2025 00:14:27 GMT-0500 (Eastern Standard Time)

---

### **Qualifications & scope**

- **Specialties:** software-samd, other
- **Device panels:** other
- **Regulatory pathways:** 510k, pma, post_market

---

• This consultant is ideally suited for medtech companies, especially those developing Software as a Medical Device (SaMD) or leveraging cloud platforms, who are preparing for or managing submissions through 510(k), PMA, or post-market phases. They are particularly valuable for mid-to-large medtech organizations seeking to optimize their Regulatory Information Management (RIM) systems, improve data

HQ: United States

Languages: English

Status: claimed

Jurisdictions: US