Kristin Miller
RN, CCRC | Med Device & Pharma Law Expert | Clinical Trial Leader | Regulatory Submissions Specialist
Highly accomplished Registered Nurse and Certified Clinical Research Coordinator with a robust background in cardiovascular and neurodegenerative disease research. Possesses advanced education including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrating a deep understanding of regulatory compliance. Proven expertise in leading complex clinical trials, managing regulatory submissions (including Emergency Use Authorization and Single-Use INDs), and ensuring adherence to all applicable federal clinical trial programs. Skilled in protocol development, patient recruitment, data management, and adverse event handling. A published author and mentor, dedicated to advancing medical research and patient care, with a strong ability to navigate intellectual property and foster collaborations.
About
Highly accomplished Registered Nurse and Certified Clinical Research Coordinator with a robust background in cardiovascular and neurodegenerative disease research. Possesses advanced education including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrating a deep understanding of regulatory compliance. Proven expertise in leading complex clinical trials, managing regulatory submissions (including Emergency Use Authorization and Single-Use INDs), and ensuring adherence to all applicable federal clinical trial programs. Skilled in protocol development, patient recruitment, data management, and adverse event handling. A published author and mentor, dedicated to advancing medical research and patient care, with a strong ability to navigate intellectual property and foster collaborations.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 20
- **Regions served:** US
- **Client types:** academic, large_medtech
- **Location:** United States (AR)
- **Availability:** available_now
- **Certifications:** HIPAA and Information Security Certification, Certified Clinical Research Coordinator, Registered Nurse, LPN certificate
### **Cruxi analysis**
- **Strength summary:** With 20 years of experience, this expert FDA regulatory consultant analyst specializes in medtech, boasting a robust background in cardiovascular and neurodegenerative disease research. Their advanced education, including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrates a deep understanding of regulatory compliance. The consultant's expertise in leading complex clinical trials, managing regulatory submissions, and ensuring adherence to federal clinical trial programs makes them uniquely valuable for medtech companies. Their experience in managing Emergency Use Authorizations, Humanitarian Use Devices, and Single-Use IND submissions showcases their ability to navigate the complex regulatory landscape. Additionally, their technical competencies in clinical trial protocol development, adverse event handling, and ensuring adherence to applicable regulatory rules further solidify their position as a trusted advisor. This consultant's unique combination of FDA experience, device expertise, regulatory depth, and track record makes them an invaluable resource for medtech companies seeking regulatory guidance and submission success.
- **Unique value:** This expert FDA regulatory consultant analyst stands out for their unique combination of FDA experience, device expertise, and regulatory depth, making them an invaluable resource for medtech companies seeking regulatory guidance and submission success. Their extensive experience in managing complex clinical trials, regulatory submissions, and federal clinical trial programs, coupled with their advanced education in Pharmaceutical and Medical Device Law, sets them apart from other consultants. By engaging with this consultant, medtech companies can tap into their expertise, ensuring a successful regulatory pathway and submission, and mitigating regulatory risks.
- **Ideal projects:** The perfect medtech client for this consultant is a company developing cardiovascular or neurology devices that requires regulatory guidance for a 510(k) or De Novo submission. This company is likely a mid-sized medtech firm with a proven product pipeline, seeking to expand its regulatory expertise and submission capabilities. The ideal project would involve a complex device with a high-risk profile, requiring extensive clinical trial data and a strong submission strategy. Engagement with this consultant would be most beneficial when the company is preparing for a pivotal submission, seeking to mitigate regulatory risks, or looking to enhance its internal regulatory capabilities. By partnering with this expert consultant, medtech companies can ensure a successful regulatory pathway and submission, leveraging their expertise in regulatory affairs and clinical trials.
- **Confidence score:** 90/100
- **Last analyzed:** Mon Jan 05 2026 15:37:36 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** clinical-trials
- **Specialties:** cardiovascular, neurology
- **Device panels:** cardiovascular, neurology
- **Regulatory pathways:** ide, hde
- **Type:** independent
- **Years of experience:** 20
- **Regions served:** US
- **Client types:** academic, large_medtech
- **Location:** United States (AR)
- **Availability:** available_now
- **Certifications:** HIPAA and Information Security Certification, Certified Clinical Research Coordinator, Registered Nurse, LPN certificate
### **Cruxi analysis**
- **Strength summary:** With 20 years of experience, this expert FDA regulatory consultant analyst specializes in medtech, boasting a robust background in cardiovascular and neurodegenerative disease research. Their advanced education, including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrates a deep understanding of regulatory compliance. The consultant's expertise in leading complex clinical trials, managing regulatory submissions, and ensuring adherence to federal clinical trial programs makes them uniquely valuable for medtech companies. Their experience in managing Emergency Use Authorizations, Humanitarian Use Devices, and Single-Use IND submissions showcases their ability to navigate the complex regulatory landscape. Additionally, their technical competencies in clinical trial protocol development, adverse event handling, and ensuring adherence to applicable regulatory rules further solidify their position as a trusted advisor. This consultant's unique combination of FDA experience, device expertise, regulatory depth, and track record makes them an invaluable resource for medtech companies seeking regulatory guidance and submission success.
- **Unique value:** This expert FDA regulatory consultant analyst stands out for their unique combination of FDA experience, device expertise, and regulatory depth, making them an invaluable resource for medtech companies seeking regulatory guidance and submission success. Their extensive experience in managing complex clinical trials, regulatory submissions, and federal clinical trial programs, coupled with their advanced education in Pharmaceutical and Medical Device Law, sets them apart from other consultants. By engaging with this consultant, medtech companies can tap into their expertise, ensuring a successful regulatory pathway and submission, and mitigating regulatory risks.
- **Ideal projects:** The perfect medtech client for this consultant is a company developing cardiovascular or neurology devices that requires regulatory guidance for a 510(k) or De Novo submission. This company is likely a mid-sized medtech firm with a proven product pipeline, seeking to expand its regulatory expertise and submission capabilities. The ideal project would involve a complex device with a high-risk profile, requiring extensive clinical trial data and a strong submission strategy. Engagement with this consultant would be most beneficial when the company is preparing for a pivotal submission, seeking to mitigate regulatory risks, or looking to enhance its internal regulatory capabilities. By partnering with this expert consultant, medtech companies can ensure a successful regulatory pathway and submission, leveraging their expertise in regulatory affairs and clinical trials.
- **Confidence score:** 90/100
- **Last analyzed:** Mon Jan 05 2026 15:37:36 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** clinical-trials
- **Specialties:** cardiovascular, neurology
- **Device panels:** cardiovascular, neurology
- **Regulatory pathways:** ide, hde
Key Highlights
- With 20 years of experience, this expert FDA regulatory consultant analyst specializes in medtech, boasting a robust background in cardiovascular and neurodegenerative disease research. Their advanced education, including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrates a deep understanding of regulatory compliance. The consultant's expertise in leading complex clinical trials, managing regulatory submissions, and ensuring adherence to federal clinic
- This expert FDA regulatory consultant analyst stands out for their unique combination of FDA experience, device expertise, and regulatory depth, making them an invaluable resource for medtech companies seeking regulatory guidance and submission success. Their extensive experience in managing complex clinical trials, regulatory submissions, and federal clinical trial programs, coupled with their advanced education in Pharmaceutical and Medical Device Law, sets them apart from other consultants. B
Certifications & Trust Signals
- 20 years experience
Buyer Snapshot
Best for
- The perfect medtech client for this consultant is a company developing cardiovascular or neurology devices that requires regulatory guidance for a 510(k) or De Novo submission. This company is likely a mid-sized medtech firm with a proven product pipeline, seeking to expand its regulatory expertise and submission capabilities. The ideal project would involve a complex device with a high-risk profi
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
20
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, neurology
Accepting New Clients:
No
