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.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Predicate Research & Substantial Equivalence Strategy, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, De Novo Strategy & Authoring, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, 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
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
