SENIOR REGULATORY AFFAIRS SPECIALIST
Joined: May 11, 2026
If your AI/ML SaMD has no predicate, I have run the De Novo path, pre-sub through eSTAR, submitted in under three months, backed by 10 years of 510(k) work. Since joining in May 2026 I have led 8 Innolitics engagements spanning 510(k), De Novo, pre-submissions, an IDE, and QMS audits, and contributed to 5 more. Before Innolitics I consulted at Medical Device Academy, and have three 510(k) clearances in gynecology and urology in the FDA database under my name. I hold a Pharmacy degree and a Masters in Regulatory Affairs (Medical Devices) & I am a certified ISO 13485 Lead Auditor. I have handled AINN responses, SIR meetings, and FDA inspection readiness, and have helped founders and C-suite teams pick the pathway that fits their timeline and budget.
I have around 10 years of combined experience in Regulatory & Quality in Medical Device industry. I have 510(k) clearances published in FDA database on my name in gynecology, urology etc device categories . I hold Masters in Regulatory Affairs and an undergraduate degree in Pharmacy. I have worked with various types of medical devices i.e AI/ML SaMD, traditional and combination products. My experience include AI/ML SaMD regulatory strategy, authoring 510(k)/ De Novo submission, Q-submissions, responding to AINN deficiencies, SIR meetings, remediation of quality system, FDA inspection readiness & implementation of QMS compliant with 21 cfr 820/ISO 13485/ ISO 9001.
I have worked with CEO/founder & C-suite executive levels helping them navigate the regulatory pathway to meet their time & investment expectations. I am passionate of bringing novel technologies to the market and seeing the impact on real patient-care.
Painting, Travel, Cooking