DEMET (DEE) GRACE SAG, PhD
Translational Medicine & Regulatory Affairs Executive | 15+ Years | Drugs, Biologics, Devices, IVDs
Translational medicine and regulatory science executive with over 15 years of experience leading end-to-end product lifecycles from discovery to market access. PhD in Molecular Genetics and Stem Cell Developmental Biology with deep expertise in integrating science, clinical development, and regulatory strategy across diverse settings. Proven ability to lead cross-functional teams and drive complex programs. Extensive experience in regulatory strategy and medical writing for drugs, biologics, ATMPs, medical devices, and IVDs/CDx (FDA, EMA, EU MDR, IVDR). Expertise spans oncology, cardiovascular, regenerative medicine, and precision diagnostics, bridging bench science and global regulatory requirements.
About
Translational medicine and regulatory science executive with over 15 years of experience leading end-to-end product lifecycles from discovery to market access. PhD in Molecular Genetics and Stem Cell Developmental Biology with deep expertise in integrating science, clinical development, and regulatory strategy across diverse settings. Proven ability to lead cross-functional teams and drive complex programs. Extensive experience in regulatory strategy and medical writing for drugs, biologics, ATMPs, medical devices, and IVDs/CDx (FDA, EMA, EU MDR, IVDR). Expertise spans oncology, cardiovascular, regenerative medicine, and precision diagnostics, bridging bench science and global regulatory requirements.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 22
- **Location:** United States
- **Availability:** available_now
- **Certifications:** other, other
### **Cruxi analysis**
- **Strength summary:** Demet (Dee) Grace Sag, PhD, offers a unique blend of 22 years of experience, deep regulatory expertise, and extensive FDA experience, making her a valuable asset for medtech companies. With a strong background in translational medicine and regulatory science, she has led end-to-end product lifecycles from discovery to market access. Her expertise spans oncology, cardiovascular, regenerative medicine, and precision diagnostics, and she has extensive experience with regulatory strategy and medical writing for various devices and IVDs. Her proven ability to lead cross-functional teams and drive complex programs is particularly valuable for medtech companies navigating the complex regulatory landscape. Her unique combination of scientific expertise, regulatory knowledge, and leadership skills makes her an exceptional choice for medtech professionals seeking guidance on FDA submissions, regulatory strategy, and medical writing.
- **Unique value:** Demet (Dee) Grace Sag, PhD, stands out as a trusted advisor for medtech companies due to her exceptional combination of deep regulatory expertise, extensive FDA experience, and strong scientific background. Her unique ability to bridge bench science and global regulatory requirements, coupled with her proven track record of leading cross-functional teams and driving complex programs, makes her a valuable asset for companies seeking guidance on regulatory strategy, medical writing, and FDA submissions.
- **Ideal projects:** Demet (Dee) Grace Sag, PhD, is an ideal fit for medtech companies developing complex devices, such as cardiovascular devices, IVDs, or SaMDs, that require expertise in regulatory strategy and medical writing. She excels in supporting companies at various stages, from startup to established players, and is well-equipped to handle first submissions, complex devices, or international expansion projects. Her unique blend of scientific expertise, regulatory knowledge, and leadership skills makes her an excellent choice for medtech companies seeking guidance on navigating the complex regulatory landscape and ensuring successful FDA submissions.
- **Confidence score:** 90/100
- **Last analyzed:** Mon Jan 05 2026 15:37:13 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** clinical-trials, international
- **Specialties:** cardiovascular, hematology, pathology, ivd, other
- **Device panels:** cardiovascular, ivd, other
- **Regulatory pathways:** 510k, pma, ide, q_sub, post_market
- **Type:** independent
- **Years of experience:** 22
- **Location:** United States
- **Availability:** available_now
- **Certifications:** other, other
### **Cruxi analysis**
- **Strength summary:** Demet (Dee) Grace Sag, PhD, offers a unique blend of 22 years of experience, deep regulatory expertise, and extensive FDA experience, making her a valuable asset for medtech companies. With a strong background in translational medicine and regulatory science, she has led end-to-end product lifecycles from discovery to market access. Her expertise spans oncology, cardiovascular, regenerative medicine, and precision diagnostics, and she has extensive experience with regulatory strategy and medical writing for various devices and IVDs. Her proven ability to lead cross-functional teams and drive complex programs is particularly valuable for medtech companies navigating the complex regulatory landscape. Her unique combination of scientific expertise, regulatory knowledge, and leadership skills makes her an exceptional choice for medtech professionals seeking guidance on FDA submissions, regulatory strategy, and medical writing.
- **Unique value:** Demet (Dee) Grace Sag, PhD, stands out as a trusted advisor for medtech companies due to her exceptional combination of deep regulatory expertise, extensive FDA experience, and strong scientific background. Her unique ability to bridge bench science and global regulatory requirements, coupled with her proven track record of leading cross-functional teams and driving complex programs, makes her a valuable asset for companies seeking guidance on regulatory strategy, medical writing, and FDA submissions.
- **Ideal projects:** Demet (Dee) Grace Sag, PhD, is an ideal fit for medtech companies developing complex devices, such as cardiovascular devices, IVDs, or SaMDs, that require expertise in regulatory strategy and medical writing. She excels in supporting companies at various stages, from startup to established players, and is well-equipped to handle first submissions, complex devices, or international expansion projects. Her unique blend of scientific expertise, regulatory knowledge, and leadership skills makes her an excellent choice for medtech companies seeking guidance on navigating the complex regulatory landscape and ensuring successful FDA submissions.
- **Confidence score:** 90/100
- **Last analyzed:** Mon Jan 05 2026 15:37:13 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** clinical-trials, international
- **Specialties:** cardiovascular, hematology, pathology, ivd, other
- **Device panels:** cardiovascular, ivd, other
- **Regulatory pathways:** 510k, pma, ide, q_sub, post_market
Key Highlights
- Demet (Dee) Grace Sag, PhD, offers a unique blend of 22 years of experience, deep regulatory expertise, and extensive FDA experience, making her a valuable asset for medtech companies. With a strong background in translational medicine and regulatory science, she has led end-to-end product lifecycles from discovery to market access. Her expertise spans oncology, cardiovascular, regenerative medicine, and precision diagnostics, and she has extensive experience with regulatory strategy and medical
- Demet (Dee) Grace Sag, PhD, stands out as a trusted advisor for medtech companies due to her exceptional combination of deep regulatory expertise, extensive FDA experience, and strong scientific background. Her unique ability to bridge bench science and global regulatory requirements, coupled with her proven track record of leading cross-functional teams and driving complex programs, makes her a valuable asset for companies seeking guidance on regulatory strategy, medical writing, and FDA submis
Certifications & Trust Signals
- 22 years experience
Buyer Snapshot
Best for
- Demet (Dee) Grace Sag, PhD, is an ideal fit for medtech companies developing complex devices, such as cardiovascular devices, IVDs, or SaMDs, that require expertise in regulatory strategy and medical writing. She excels in supporting companies at various stages, from startup to established players, and is well-equipped to handle first submissions, complex devices, or international expansion projec
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support
Pathways Supported:
PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Years Experience:
22
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, ivd, other
Technology Types:
samd, ai_ml, ivd_test, combo_product
Accepting New Clients:
No
