Samir Shah
Regulatory Affairs for Digital Health, Combination Products, and Medical Devices
- Role
- Director, Regulatory Cmc, Medical Devices, and Combination Products at AstraZeneca
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Samir Shah
Led regulatory strategy, submission, and negotiations of PROAIR DIGIHALER, AIRDUO…
Experience
Director, Regulatory Cmc, Medical Devices, and Combination Products
Sep 2019 — Present · Gaithersburg, MD, US
Provide regulatory strategies for software, medical devices, and combination products to cure and prevent disease in the oncology, respiratory, and cardiovascular therapeutic areas, including over-the-counter (nonprescription, with ACNU)Advocate for regulations that lead to predictable expectations in the areas of drug/device combination products and digital health (including medical device cybersecurity)Mentor junior scientists/engineers and graduate students in the areas of effective communication, networking, rapid learning strategies, pharmaceutical / medical device careers, time management, and stress management.
Education
Case Western Reserve University
B.S., Polymer Science Engineering
1993 — 1997
Thomas Jefferson High School for Science and Technology
Diploma, Science / Engineering
1989 — 1993
Pennsylvania State University College of Medicine
Biomaterials / Bionanotechnology Summer Fellowship
2003 — 2004
Wake Forest University School of Medicine
PhD, Biomedical Engineering
2002 — 2006
Skills
- Copd
- Minitab
- Formulation
- Medical Diagnostics
- Clinical Development
- Dropbox
- Regulatory Affairs
- Ehealth
- Respiratory Products
- Meeting Facilitation
- Pharmaceutical Industry
- Fda
- Pharmacokinetics
- Cystic Fibrosis
- In Vitro
- Respiratory Disease
- Gmp
- Design of Experiments
- Evernote
- Drug Delivery
- Productivity Tools
- Regulatory Requirements
- Medical Device Connectivity
- Medical Devices
- Clinical Trials
- Regulatory Guidelines
- Regulatory Filings
- Regulatory Submissions
- In Vivo
- Inhalation
- Chemistry
- Public Speaking
- Productivity Software
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