Mary Beth Kepler has been working as a Chief Compliance Officer at Cerus Endovascular since 2017. Furthermore, this person has an employment history at more than 14 companies using similar skills. Mary has a total work experience of 34+ years. Mary Beth Kepler studied at the University of Phoenix from 1998 to 2000. Now they live in San Francisco, California region. Find this professional's current e-mail and phone through SoftwareOfficial search.
Name variants:
Maria Kepler,
Marie Kepler,
Mare Kepler,
Mame Kepler,
Mamie Kepler,
Mimi Kepler,
Moll Kepler,
Molly Kepler,
Polly Kepler,
Mae Kepler,
May Kepler,
Mollie Kepler,
Minnie Kepler
Last updated Jun 05, 2024
Contact Information
Last Update
Jul 13, 2022
Email
mn**@comcast.net, ke**@berlinheart.com
Location
San Francisco, CA
Company
Workplace
Colleagues
Work History
Senior Director, Clinical Studies and Regulatory Affairs
Oversee clinical studies and regulatory affairs activities including post market vigilance, FDA communications and any clinical study needs. Work cross-functionally supporting company goals ...
Nov 2013 — Mar 2017
Senior Director Clinical Engineering and Research
12988 Valley View Rd, Eden Prairie, MN 55344
Responsible for the clinical studies and field team.
Prepared the Phase 1 Feasibility Data Report.
Contributed clinical sections that gained CE Mark Approval.
Lead the clinical study des...
Jan 2012 — Nov 2013
Vice President, Regulatory Affairs and Quality Assurance
Responsible for the IDE and PMA for the Berlin Heart EXCOR pediatric VAD. From study design through approval, we designed implemented and report the US experience to the FDA and FDA panel. C...
Apr 2006 — Jan 2012
Product Manager
Worked on the 1st and 2nd generation saphenous vein harvestor. Provided customer training, facilitated customer feedback into the 2nd generation. Worked cross-functionally with our colleague...
May 2006 — Nov 2006
Clinical and Regulatory Consultant
401 Carlson Pkwy, Minnetonka, MN 55305
Provide Clinical and Regulatory assistance to companies. Primary focus on US FDA Clinical Trials and CE Mark/OUS trials. Key strengths in trial design, KOL communications, and clinical opera...
from Aug 2006
Director, Clinical Affairs
Oversight of the on-going EU trial for CE Mark approval. Began mid-trial and continued through reporting to EU regulatory agencies seeking CE approval. Managed the EU and US Clinical Affairs...
Dec 2004 — May 2006
Senior Clinical Study Manager; Principle Education Consultant
710 Medtronic Pkwy, Minneapolis, MN 55432
Managed a large, double-blind, randomized, IDE trial for a CRT-D device. Trained field personnel and customers on CRT and Heart Failure therapies.
Oct 2002 — Dec 2004
Manager, Clinical and Regulatory Affairs
Hired to manage proposed US pivotal trial and help oversee EU trial. Company went out of business before the start of the trial.
Jun 2002 — Oct 2002
Manager, Clinical and Regulatory Affairs
22 Cherry Hill Dr, Danvers, MA 01923
Hired to manage the US clinical trial for the Abiocor. Supported first US patient and provided site training for study sites.
Aug 2001 — Sep 2001
Clinical Engineer Manager
Supported patients on multiple types of devices at the hospital for the artificial heart program. Attended implants and explants, provided daily care and assesment of device function. Traine...
Dec 1993 — Aug 2001
Clinical Engineer Manager
Provided support to North American sites for IDE study and implants.
Trained US sites. Provided 24-hour Clinical and Technical Support for customers globally.
Helped with the IDE and PMA ...
Dec 1993 — Jul 2001
Senior Clinical Engineer
Provide clinical and technical support for global customers. Supported IDE efforts for original PMA approval. Trained customers worldwide.
Mar 1995 — Jul 1997
Senior Director of Clinical Research at Sunshine Heart, Inc
12988 Valley View Rd, Eden Prairie, MN 55344
At Sunshine Heart, we have a therapy that changes how heart failure patients are managed. Our product, C-Pulse®, is a technology that can have a tremendous impact on a patients quality of li...
Education
1998 — 2000
1986 — 1993
Occupations
Executive
Chairperson
Director of Quality Control
Senior Director
Chief Executive
Compliance Manager
Senior Manager
Operations Manager
Skills
Medical Devices
Fda
Clinical Trials
Clinical Research
Regulatory Affairs
Quality Assurance
Pma
Cardiology
Clinical Development
Biotechnology
Cross Functional Team Leadership
Biomedical Engineering
Ce Marking
Healthcare
Hospitals
Iso 13485
Product Development
Product Launch
Quality System
Regulatory Submissions
FAQs about Mary Beth Kepler
What's the main profession of Mary Beth Kepler?
The expert is a President.
What jobs is Mary a professional at?
Mary is proficient at such jobs as Executive and Chairperson.
Where is Mary Beth Kepler currently located?
The professional is currently located in San Francisco, California.
Does Mary have the email address?
mn**@comcast.net and ke**@berlinheart.com is Mary's email address.
Where did Mary Beth Kepler work?
The expert worked at Cerus Endovascular, Berlin Heart Gmbh.
What education does Mary Beth Kepler have?
Mary studied at the University of Phoenix from 1998 to 2000.
Are there any industries, that Mary Beth Kepler works in?
Mary works in Medical Devices industry.
Are there any skills, that Mary Beth Kepler has?
This person has the following skills: Medical Devices, Fda, Clinical Trials, Clinical Research, Regulatory Affairs, Quality Assurance, Pma, Cardiology, Clinical Development, and Biotechnology.