Gayathri Manoj
Regulatory Affairs Professional | 4+ Yrs Exp | 510(k), De Novo, Clinical Trials | Biologics & Medical Devices
Gayathri Manoj is a regulatory affairs professional with over 4 years of experience in biologics, medical devices, and the clinical space. She possesses a proven track record across a diverse range of submissions and strategies, including 510(k), De Novo, and Breakthrough designations, as well as Common Technical Documents (CTDs).
About
Gayathri Manoj is a regulatory affairs professional with over 4 years of experience in biologics, medical devices, and the clinical space. She possesses a proven track record across a diverse range of submissions and strategies, including 510(k), De Novo, and Breakthrough designations, as well as Common Technical Documents (CTDs).
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 4
- **Client types:** startup, sme
- **Location:** United States (Massachusetts)
- **Availability:** in_2_weeks
### **Cruxi analysis**
- **Strength summary:** Gayathri Manoj offers a focused regulatory affairs skillset, particularly valuable for smaller companies navigating the complexities of early-stage medical device submissions. With 4+ years of experience, her expertise spans biologics, medical devices, and clinical trials, with a strong emphasis on 510(k) traditional and De Novo pathways. Her experience with orthopedic, dental, radiology, and software as a medical device (SaMD) provides a diverse background. This combination makes her well-suited for companies seeking efficient and cost-effective support for Class I and II device submissions.
- **Unique value:** Gayathri offers a cost-effective, focused expertise in 510(k) and De Novo submissions for Class I and II devices, making her an ideal partner for startups and smaller companies seeking efficient regulatory guidance without the overhead of larger consulting firms.
- **Ideal projects:** The ideal project for Gayathri would involve a small to medium-sized company seeking 510(k) clearance or De Novo classification for a Class I or II medical device, particularly in the orthopedic, dental, radiology, or SaMD spaces. Companies needing assistance with clinical trial submissions or international regulatory strategies would also benefit from her expertise. Given her hourly pricing structure, startups or companies with budget constraints requiring focused regulatory support are a good fit.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:11:49 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, clinical-trials, international
- **Device classes:** class-i, class-ii
- **Specialties:** orthopedic, dental, software-samd, radiology, clinical trials
- **Regulatory pathways:** 510k, de_novo
- **Type:** independent
- **Years of experience:** 4
- **Client types:** startup, sme
- **Location:** United States (Massachusetts)
- **Availability:** in_2_weeks
### **Cruxi analysis**
- **Strength summary:** Gayathri Manoj offers a focused regulatory affairs skillset, particularly valuable for smaller companies navigating the complexities of early-stage medical device submissions. With 4+ years of experience, her expertise spans biologics, medical devices, and clinical trials, with a strong emphasis on 510(k) traditional and De Novo pathways. Her experience with orthopedic, dental, radiology, and software as a medical device (SaMD) provides a diverse background. This combination makes her well-suited for companies seeking efficient and cost-effective support for Class I and II device submissions.
- **Unique value:** Gayathri offers a cost-effective, focused expertise in 510(k) and De Novo submissions for Class I and II devices, making her an ideal partner for startups and smaller companies seeking efficient regulatory guidance without the overhead of larger consulting firms.
- **Ideal projects:** The ideal project for Gayathri would involve a small to medium-sized company seeking 510(k) clearance or De Novo classification for a Class I or II medical device, particularly in the orthopedic, dental, radiology, or SaMD spaces. Companies needing assistance with clinical trial submissions or international regulatory strategies would also benefit from her expertise. Given her hourly pricing structure, startups or companies with budget constraints requiring focused regulatory support are a good fit.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:11:49 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, clinical-trials, international
- **Device classes:** class-i, class-ii
- **Specialties:** orthopedic, dental, software-samd, radiology, clinical trials
- **Regulatory pathways:** 510k, de_novo
Key Highlights
- Gayathri Manoj offers a focused regulatory affairs skillset, particularly valuable for smaller companies navigating the complexities of early-stage medical device submissions. With 4+ years of experience, her expertise spans biologics, medical devices, and clinical trials, with a strong emphasis on 510(k) traditional and De Novo pathways. Her experience with orthopedic, dental, radiology, and software as a medical device (SaMD) provides a diverse background. This combination makes her well-suite
- Gayathri offers a cost-effective, focused expertise in 510(k) and De Novo submissions for Class I and II devices, making her an ideal partner for startups and smaller companies seeking efficient regulatory guidance without the overhead of larger consulting firms.
Certifications & Trust Signals
- 4 years experience
Buyer Snapshot
Best for
- The ideal project for Gayathri would involve a small to medium-sized company seeking 510(k) clearance or De Novo classification for a Class I or II medical device, particularly in the orthopedic, dental, radiology, or SaMD spaces. Companies needing assistance with clinical trial submissions or international regulatory strategies would also benefit from her expertise. Given her hourly pricing struc
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)
Pathways Supported:
Traditional 510(k), De Novo
Device Types Supported:
SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
4
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
hourly
Accepting New Clients:
Yes
