Kelsey N. Roberts
Regulatory Affairs Specialist with 9.5 years of experience in medtech.
A committed and ambitious regulatory affairs professional with 9.5 years of comprehensive experience in the medical device industry. Proven track record of success, evidenced by securing >10 510(k) clearances for orthopedic devices. Expertise spans the entire product lifecycle, from developing premarket regulatory strategies and authoring submissions to providing post-market support for top MedTech companies. Skilled in advising cross-functional teams on global regulatory requirements, risk evaluation, labeling, and QMS compliance. Passionate about facilitating innovation to bring new technologies to patients and healthcare providers, with deep experience in orthopedics and advanced wound care.
About
A committed and ambitious regulatory affairs professional with 9.5 years of comprehensive experience in the medical device industry. Proven track record of success, evidenced by securing >10 510(k) clearances for orthopedic devices. Expertise spans the entire product lifecycle, from developing premarket regulatory strategies and authoring submissions to providing post-market support for top MedTech companies. Skilled in advising cross-functional teams on global regulatory requirements, risk evaluation, labeling, and QMS compliance. Passionate about facilitating innovation to bring new technologies to patients and healthcare providers, with deep experience in orthopedics and advanced wound care.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 9.5
- **510(k)s submitted (self-reported):** 10
- **Ex-Big MedTech:** Yes
- **Regions served:** US, CA, EU, LATAM
- **Client types:** startup, sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
- **Certifications:** RAPS Certificate Program
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### **Cruxi analysis**
- **Strength summary:** With 9.5 years of dedicated medtech experience, Kelsey N. Roberts offers a powerful combination of deep specialization and a proven track record of success. Her expertise is most evident in her achievement of securing over 10 510(k) clearances, primarily for Class II orthopedic devices, demonstrating a clear mastery of this critical regulatory pathway. Drawing from her background supporting top MedTech companies, she provides comprehensive, full-lifecycle support—from initial premarket strategy and Q-Submission guidance to robust post-market compliance and QMS development. For medtech companies in the orthopedics and advanced wound care spaces, Kelsey is an invaluable asset who de-risks the submission process and provides a clear, strategic path to market.
- **Unique value:** Kelsey's distinct advantage is her proven, specialized expertise in securing 510(k) clearance for orthopedic medical devices. Her track record of over 10 successful clearances is a direct testament to her deep understanding of the FDA's expectations for this specific device category. This focused mastery, combined with her ability to manage the entire regulatory lifecycle, makes her an exceptionally effective and reliable partner for orthopedic innovators.
- **Ideal projects:** The ideal project for Kelsey is a startup or SME developing a Class II orthopedic or advanced wound care device targeting US, EU, or Canadian markets. She is the perfect partner for companies navigating the 510(k) pathway for the first time or seeking to strengthen their submission strategy for an implantable product. Companies will gain maximum value by engaging her for end-to-end 510(k) preparation, from predicate analysis and test strategy development to full submission authoring and responding to FDA deficiencies. Her expertise is also ideal for established companies needing specialized support for QMS setup or managing post-market obligations for their commercialized devices.
- **Last analyzed:** Sun Jan 04 2026 22:14:14 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, international, qms, clinical-trials
- **Device classes:** class-ii
- **Specialties:** orthopedic, general-hospital
- **Device panels:** orthopedic, general_surgery, other
- **Regulatory pathways:** 510k, q_sub, post_market
---
- **Type:** independent
- **Years of experience:** 9.5
- **510(k)s submitted (self-reported):** 10
- **Ex-Big MedTech:** Yes
- **Regions served:** US, CA, EU, LATAM
- **Client types:** startup, sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
- **Certifications:** RAPS Certificate Program
---
### **Cruxi analysis**
- **Strength summary:** With 9.5 years of dedicated medtech experience, Kelsey N. Roberts offers a powerful combination of deep specialization and a proven track record of success. Her expertise is most evident in her achievement of securing over 10 510(k) clearances, primarily for Class II orthopedic devices, demonstrating a clear mastery of this critical regulatory pathway. Drawing from her background supporting top MedTech companies, she provides comprehensive, full-lifecycle support—from initial premarket strategy and Q-Submission guidance to robust post-market compliance and QMS development. For medtech companies in the orthopedics and advanced wound care spaces, Kelsey is an invaluable asset who de-risks the submission process and provides a clear, strategic path to market.
- **Unique value:** Kelsey's distinct advantage is her proven, specialized expertise in securing 510(k) clearance for orthopedic medical devices. Her track record of over 10 successful clearances is a direct testament to her deep understanding of the FDA's expectations for this specific device category. This focused mastery, combined with her ability to manage the entire regulatory lifecycle, makes her an exceptionally effective and reliable partner for orthopedic innovators.
- **Ideal projects:** The ideal project for Kelsey is a startup or SME developing a Class II orthopedic or advanced wound care device targeting US, EU, or Canadian markets. She is the perfect partner for companies navigating the 510(k) pathway for the first time or seeking to strengthen their submission strategy for an implantable product. Companies will gain maximum value by engaging her for end-to-end 510(k) preparation, from predicate analysis and test strategy development to full submission authoring and responding to FDA deficiencies. Her expertise is also ideal for established companies needing specialized support for QMS setup or managing post-market obligations for their commercialized devices.
- **Last analyzed:** Sun Jan 04 2026 22:14:14 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, international, qms, clinical-trials
- **Device classes:** class-ii
- **Specialties:** orthopedic, general-hospital
- **Device panels:** orthopedic, general_surgery, other
- **Regulatory pathways:** 510k, q_sub, post_market
---
Key Highlights
- With 9.5 years of dedicated medtech experience, Kelsey N. Roberts offers a powerful combination of deep specialization and a proven track record of success. Her expertise is most evident in her achievement of securing over 10 510(k) clearances, primarily for Class II orthopedic devices, demonstrating a clear mastery of this critical regulatory pathway. Drawing from her background supporting top MedTech companies, she provides comprehensive, full-lifecycle support—from initial premarket strategy
- Kelsey's distinct advantage is her proven, specialized expertise in securing 510(k) clearance for orthopedic medical devices. Her track record of over 10 successful clearances is a direct testament to her deep understanding of the FDA's expectations for this specific device category. This focused mastery, combined with her ability to manage the entire regulatory lifecycle, makes her an exceptionally effective and reliable partner for orthopedic innovators.
Certifications & Trust Signals
- 9.5 years experience
- 10 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project for Kelsey is a startup or SME developing a Class II orthopedic or advanced wound care device targeting US, EU, or Canadian markets. She is the perfect partner for companies navigating the 510(k) pathway for the first time or seeking to strengthen their submission strategy for an implantable product. Companies will gain maximum value by engaging her for end-to-end 510(k) preparat
HQ:
United States
Languages:
English
Status:
claimed
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, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
9
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
orthopedic, general_surgery, other
Technology Types:
implantable
Accepting New Clients:
Yes
