Haewon Park
Regulatory Affairs Consultant for Medical Devices and Cosmetics
Regulatory Affairs Consultant with 5+ years of experience leading 510(k) submissions, Q-Submissions, and post-market compliance for medical devices, cosmetics, and consumer health technologies. Expertise in Class II devices and a Ph.D. in Environmental Science enable me to provide end-to-end support, including regulatory gap analysis, submission strategy, labeling/claims review, and quality documentation.
About
Regulatory Affairs Consultant with 5+ years of experience leading 510(k) submissions, Q-Submissions, and post-market compliance for medical devices, cosmetics, and consumer health technologies. Expertise in Class II devices and a Ph.D. in Environmental Science enable me to provide end-to-end support, including regulatory gap analysis, submission strategy, labeling/claims review, and quality documentation.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 5
- **510(k)s submitted (self-reported):** 3
- **Regions served:** US
- **Client types:** startup
- **Location:** United States (New Jersey)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** Haewon Park offers a valuable blend of scientific rigor and practical regulatory experience, particularly beneficial for companies navigating the U.S. FDA landscape. With 5+ years of experience focused on 510(k) submissions, Q-Submissions, and post-market compliance, coupled with a Ph.D. in Environmental Science, she brings a deep understanding of both the scientific and regulatory aspects of medical devices, cosmetics (MoCRA), and consumer health technologies. Her specialization in Class II devices across cardiovascular, ophthalmic, software-as-a-medical-device (SaMD), and general hospital applications makes her a well-rounded consultant for a variety of projects. The ability to communicate in both English and Korean further enhances her value for international clients, especially those based in Korea.
- **Unique value:** Haewon Park's unique value lies in her combination of a Ph.D.-level scientific understanding, hands-on experience with 510(k) submissions, and a specific focus on supporting U.S. and international startups, especially those based in Korea, in the medical device and consumer health technology sectors.
- **Ideal projects:** The ideal project for Haewon Park involves assisting U.S. or international startups, especially Korea-based companies, with Class II medical devices seeking 510(k) clearance. Projects requiring assistance with regulatory gap analysis, submission strategy, labeling/claims review, quality documentation, and U.S. market-entry planning align well with her expertise. Companies developing cardiovascular, ophthalmic, SaMD, or general hospital devices would particularly benefit from her specialized knowledge. Her experience is well-suited for projects needing a consultant to build sustainable compliance foundations and accelerate product readiness.
- **Last analyzed:** Sun Dec 14 2025 01:12:18 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, qms, clinical-trials
- **Device classes:** class-ii
- **Specialties:** cardiovascular, ophthalmic, software-samd
- **Device panels:** cardiovascular, ophthalmic, general hospital
- **Regulatory pathways:** 510k, de_novo, q_sub
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- **Type:** independent
- **Years of experience:** 5
- **510(k)s submitted (self-reported):** 3
- **Regions served:** US
- **Client types:** startup
- **Location:** United States (New Jersey)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** Haewon Park offers a valuable blend of scientific rigor and practical regulatory experience, particularly beneficial for companies navigating the U.S. FDA landscape. With 5+ years of experience focused on 510(k) submissions, Q-Submissions, and post-market compliance, coupled with a Ph.D. in Environmental Science, she brings a deep understanding of both the scientific and regulatory aspects of medical devices, cosmetics (MoCRA), and consumer health technologies. Her specialization in Class II devices across cardiovascular, ophthalmic, software-as-a-medical-device (SaMD), and general hospital applications makes her a well-rounded consultant for a variety of projects. The ability to communicate in both English and Korean further enhances her value for international clients, especially those based in Korea.
- **Unique value:** Haewon Park's unique value lies in her combination of a Ph.D.-level scientific understanding, hands-on experience with 510(k) submissions, and a specific focus on supporting U.S. and international startups, especially those based in Korea, in the medical device and consumer health technology sectors.
- **Ideal projects:** The ideal project for Haewon Park involves assisting U.S. or international startups, especially Korea-based companies, with Class II medical devices seeking 510(k) clearance. Projects requiring assistance with regulatory gap analysis, submission strategy, labeling/claims review, quality documentation, and U.S. market-entry planning align well with her expertise. Companies developing cardiovascular, ophthalmic, SaMD, or general hospital devices would particularly benefit from her specialized knowledge. Her experience is well-suited for projects needing a consultant to build sustainable compliance foundations and accelerate product readiness.
- **Last analyzed:** Sun Dec 14 2025 01:12:18 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, qms, clinical-trials
- **Device classes:** class-ii
- **Specialties:** cardiovascular, ophthalmic, software-samd
- **Device panels:** cardiovascular, ophthalmic, general hospital
- **Regulatory pathways:** 510k, de_novo, q_sub
---
Key Highlights
- Haewon Park offers a valuable blend of scientific rigor and practical regulatory experience, particularly beneficial for companies navigating the U.S. FDA landscape. With 5+ years of experience focused on 510(k) submissions, Q-Submissions, and post-market compliance, coupled with a Ph.D. in Environmental Science, she brings a deep understanding of both the scientific and regulatory aspects of medical devices, cosmetics (MoCRA), and consumer health technologies. Her specialization in Class II dev
- Haewon Park's unique value lies in her combination of a Ph.D.-level scientific understanding, hands-on experience with 510(k) submissions, and a specific focus on supporting U.S. and international startups, especially those based in Korea, in the medical device and consumer health technology sectors.
Certifications & Trust Signals
- 5 years experience
- 3 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project for Haewon Park involves assisting U.S. or international startups, especially Korea-based companies, with Class II medical devices seeking 510(k) clearance. Projects requiring assistance with regulatory gap analysis, submission strategy, labeling/claims review, quality documentation, and U.S. market-entry planning align well with her expertise. Companies developing cardiovascular
HQ:
United States
Languages:
English, Korean
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 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, Pre-Sub / Q-Sub
Device Types Supported:
SaMD, Medical device
Supports Predicate Research:
Yes
Years Experience:
5
Num510k Submitted:
3
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, ophthalmic, general hospital
Technology Types:
samd
Engagement Models:
hourly
Accepting New Clients:
Yes
