Miriam Provost is a high-level professional, working in Transmedics, Inc main office of which is in 379. as a Vice President, Us Regulatory and Fda Relations from 2018. This person gained professional experience in more than six positions at various companies. Miriam Provost went to the University of Pennsylvania and received education from 1984 to 1989. Vienna, Virginia is the area, where this professional was lastly known to live. This person's email address and phone can be easily accessed through this website by request.
Name variants:
Myriam Provost,
Mimi Provost,
Miri Provost,
Mira Provost
Last updated Jun 09, 2024
Contact Information
Last Update
Jul 5, 2022
Email
mp**@transmedics.com, mp**@biologicsconsulting.com
Location
Vienna, VA
Company
Transmedics, Inc.
Workplace
Vice President, Us Regulatory and Fda Relations
Work History
Vice President, Us Regulatory and Fda Relations
200 Minuteman Rd SUITE 302, Andover, MA 01810
Responsible for leading and managing all FDA related matters, including all FDA communications; and regulatory submissions and related processes, management of US Regulatory support team and...
from Feb 2018
Senior Consultant, Medical Devices
1555 King St SUITE 300, Alexandria, VA 22314
Prepares FDA submissions, including 510(k)s, IDEs, PreIDEs, PMAs, 513g, HDE, Requests for Designation
Serve as contact person for FDA and interacts with FDA on behalf of clients
Provides ...
Sep 2008 — Feb 2018
Deputy Director
10903 New Hampshire Ave, Silver Spring, MD 20903
One of two deputy directors of ODE, comprised of approximately 350 scientists, engineers, medical officers and support staff responsible for premarket review and approval of all medical dev...
Jul 2005 — Sep 2007
Deputy Division Director
10903 New Hampshire Ave, Silver Spring, MD 20903
Had oversight (and sign-off authority) for two branches in DGRND (General Surgical Devices Branch and Plastic and Reconstructive Surgical Devices Branch). Provided leadership and technical a...
Dec 2001 — Mar 2005
Branch Chief
10903 New Hampshire Ave, Silver Spring, MD 20903
Responsible for assigning and managing the premarket review work (including 510(k)s, IDEs, IDE supplements, PMAs and PMA supplements) of subordinate staff. Prepared FDA Advisory panel presen...
May 2000 — Dec 2001
Scientific Reviewer
10903 New Hampshire Ave, Silver Spring, MD 20903
Scientific reviewer for 510(k)s, IDEs, PMAs for Gastroenterolgy and Renal Devices (Dialysis, Extracorporeal Therapies, Organ Preservation solutions and Devices, Biliary and Esophageal Stents)
Sep 1994 — Jun 2000
Education
1984 — 1989
1979 — 1983
Occupations
Executive
Vice President
Senior Advisor
Chief Executive
Advisor
Skills
Fda
Medical Devices
Regulatory Affairs
Clinical Development
Regulatory Requirements
Clinical Trials
Regulatory Submissions
Biotechnology
Biopharmaceuticals
Validation
Change Control
Quality System
Capa
V&V
Gmp
U.s. Food and Drug Administration
Technology Transfer
Gxp
21 Cfr Part 11