Sunita Teekasingh
Regulatory Affairs Strategy Director | 15+ Yrs Global Medtech & IVD Compliance | FDA Clearances & Crisis Management
Sunita Teekasingh is a highly accomplished Regulatory Affairs Strategy Director with over 15 years of comprehensive experience in leading global regulatory strategy for medical devices and IVDs. She has a proven expertise in navigating complex product portfolios (over 9,000 SKUs across 130+ geographies) and ensuring compliance in major markets including the U.S., EU, Canada, and Asia-Pacific. Sunita is adept at developing and implementing high-level strategies for 510(k) submissions, IVDR compliance, and high-stakes crisis management, including recovering denied PMAs and resolving DOJ investigations. She possesses an exceptional ability to serve as a strategic liaison with global health authorities and provide indirect management to project teams, driving faster-than-industry-average review times and protecting company revenue.
About
Sunita Teekasingh is a highly accomplished Regulatory Affairs Strategy Director with over 15 years of comprehensive experience in leading global regulatory strategy for medical devices and IVDs. She has a proven expertise in navigating complex product portfolios (over 9,000 SKUs across 130+ geographies) and ensuring compliance in major markets including the U.S., EU, Canada, and Asia-Pacific. Sunita is adept at developing and implementing high-level strategies for 510(k) submissions, IVDR compliance, and high-stakes crisis management, including recovering denied PMAs and resolving DOJ investigations. She possesses an exceptional ability to serve as a strategic liaison with global health authorities and provide indirect management to project teams, driving faster-than-industry-average review times and protecting company revenue.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 58
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC
- **Client types:** startup, sme, large_medtech
- **Location:** United States
- **Availability:** available_now
- **Certifications:** Registered Nurse, Critical Care Registered Nurse
### **Cruxi analysis**
- **Strength summary:** With 15 years of experience specializing in medtech and IVD compliance, this consultant is uniquely valuable for their regulatory expertise depth in navigating complex product portfolios across 130+ geographies, including the U.S., EU, Canada, and Asia-Pacific. Their exceptional ability to develop and implement high-level strategies for 510(k) submissions, IVDR compliance, and high-stakes crisis management has led to 58 FDA clearances with significantly faster-than-industry-average review times. Their expertise spans strategic oversight for 510(k) submissions, IVDR compliance, and high-stakes crisis management, including recovering denied PMAs and resolving DOJ investigations. Additionally, they possess extensive knowledge of critical regulatory standards and demonstrate proficiency in developing robust quality processes, risk management frameworks, and compliance training programs. This combination of expertise, experience, and technical skills makes them an invaluable asset for medtech companies seeking regulatory excellence.
- **Unique value:** This consultant's unique combination of 15 years of medtech experience, FDA-regulatory body expertise, technical competencies in SaMD, AI, and cloud-based platforms, and a proven track record of achieving faster-than-industry-average review times makes them stand out as a valuable resource for medtech companies seeking regulatory excellence.
- **Ideal projects:** This consultant excels in medtech projects involving complex devices (Class I-III), cardiovascular systems, robotic devices with AI, software platforms, implantable neurostimulation, and IVD diagnostics. They are best suited for projects requiring 510(k) submissions, IVDR compliance, and high-stakes crisis management, particularly those involving international expansion, first submissions, and complex global registration transfers. Medtech companies with a need for regulatory strategy development, quality process implementation, and crisis management will benefit from engaging this consultant early in their project lifecycle, especially those in the startup, SME, or large medtech stages.
- **Confidence score:** 90/100
- **Last analyzed:** Sat Dec 20 2025 10:14:08 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, qms, international, de_novo
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** cardiovascular, neurology, ivd, software-samd, regulatory strategy, risk management, quality system implementation, quality management systems, other
- **Device panels:** cardiovascular, neurology, ivd, other
- **Regulatory pathways:** 510k, pma, ide, post_market, de_novo
- **Type:** independent
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 58
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC
- **Client types:** startup, sme, large_medtech
- **Location:** United States
- **Availability:** available_now
- **Certifications:** Registered Nurse, Critical Care Registered Nurse
### **Cruxi analysis**
- **Strength summary:** With 15 years of experience specializing in medtech and IVD compliance, this consultant is uniquely valuable for their regulatory expertise depth in navigating complex product portfolios across 130+ geographies, including the U.S., EU, Canada, and Asia-Pacific. Their exceptional ability to develop and implement high-level strategies for 510(k) submissions, IVDR compliance, and high-stakes crisis management has led to 58 FDA clearances with significantly faster-than-industry-average review times. Their expertise spans strategic oversight for 510(k) submissions, IVDR compliance, and high-stakes crisis management, including recovering denied PMAs and resolving DOJ investigations. Additionally, they possess extensive knowledge of critical regulatory standards and demonstrate proficiency in developing robust quality processes, risk management frameworks, and compliance training programs. This combination of expertise, experience, and technical skills makes them an invaluable asset for medtech companies seeking regulatory excellence.
- **Unique value:** This consultant's unique combination of 15 years of medtech experience, FDA-regulatory body expertise, technical competencies in SaMD, AI, and cloud-based platforms, and a proven track record of achieving faster-than-industry-average review times makes them stand out as a valuable resource for medtech companies seeking regulatory excellence.
- **Ideal projects:** This consultant excels in medtech projects involving complex devices (Class I-III), cardiovascular systems, robotic devices with AI, software platforms, implantable neurostimulation, and IVD diagnostics. They are best suited for projects requiring 510(k) submissions, IVDR compliance, and high-stakes crisis management, particularly those involving international expansion, first submissions, and complex global registration transfers. Medtech companies with a need for regulatory strategy development, quality process implementation, and crisis management will benefit from engaging this consultant early in their project lifecycle, especially those in the startup, SME, or large medtech stages.
- **Confidence score:** 90/100
- **Last analyzed:** Sat Dec 20 2025 10:14:08 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, qms, international, de_novo
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** cardiovascular, neurology, ivd, software-samd, regulatory strategy, risk management, quality system implementation, quality management systems, other
- **Device panels:** cardiovascular, neurology, ivd, other
- **Regulatory pathways:** 510k, pma, ide, post_market, de_novo
Key Highlights
- With 15 years of experience specializing in medtech and IVD compliance, this consultant is uniquely valuable for their regulatory expertise depth in navigating complex product portfolios across 130+ geographies, including the U.S., EU, Canada, and Asia-Pacific. Their exceptional ability to develop and implement high-level strategies for 510(k) submissions, IVDR compliance, and high-stakes crisis management has led to 58 FDA clearances with significantly faster-than-industry-average review times.
- This consultant's unique combination of 15 years of medtech experience, FDA-regulatory body expertise, technical competencies in SaMD, AI, and cloud-based platforms, and a proven track record of achieving faster-than-industry-average review times makes them stand out as a valuable resource for medtech companies seeking regulatory excellence.
Certifications & Trust Signals
- 15 years experience
- 58 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- This consultant excels in medtech projects involving complex devices (Class I-III), cardiovascular systems, robotic devices with AI, software platforms, implantable neurostimulation, and IVD diagnostics. They are best suited for projects requiring 510(k) submissions, IVDR compliance, and high-stakes crisis management, particularly those involving international expansion, first submissions, and com
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, PMA
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
15
Num510k Submitted:
58
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, neurology, ivd, other
Technology Types:
samd, ai_ml, cloud_platform, implantable, ivd_test, combo_product
Accepting New Clients:
No
