We found the following information about Darren Demerritt at Renu Medical, Inc., where this professional has worked as a Director of Regulatory Affairs and Quality Assurance since 2018. Darren's total work experience is over 13 years, during which time they had at least six jobs at different companies to develop skills. Darren studied at the Eastern Washington University from 2001 to 2005. Currently, Darren is located in Bothell, Washington. You can contact with Darren by searching for phone number or email address or find further information by requesting access to the person's further details from us.
Name variants:
Darren Demerritt
Last updated May 03, 2024
Contact Information
Last Update
Jul 13, 2022
Email
dl**@gmail.com, da**@physio-control.com
Location
Bothell, WA
Company
Workplace
Director of Regulatory Affairs and Quality Assurance
Industry
Hospital & Health Care
Colleagues
Work History
Director of Regulatory Affairs and Quality Assurance
830 80Th St southwest SUITE 100, Everett, WA 98203
Responsible for all Quality and Regulatory activities for ReNu Medical, Inc.
from Oct 2018
Senior Regulatry Affairs Specialist
11811 Willows Rd northeast, Redmond, WA 98052
worked with new product development and prepared PMA applications, resolved PMA deficiencies and provided regulatory guidance on sustaining engineering changes.
Oct 2015 — Oct 2018
Senior Regulatory Affairs Specialist
Ensure FDA and international compliance, registrations and submissions to bring new product to market, post market surveillance, audits and inspections, design controls, managed adverse even...
Apr 2010 — Oct 2015
Regulatory Affairs Specialist
21919 30Th Dr southeast, Bothell, WA 98021
Ensure FDA, ISO 13485 CMDCAS compliance. Conduct Internal Audits, Manage CAPA system, Complaint Handling System, etc.
Apr 2009 — Apr 2010
Quality Engineer
350 Hills St SUITE 106, Richland, WA 99354
Worked with medical devices in regulatory affairs and quality assurance, built quality management system to ensure FDA compliance along with ISO 13485 Certification. Managed complaint files,...
Jul 2005 — Apr 2009
Education
2001 — 2005
1998 — 2000
Occupations
IT Professional
Software Tester
Executive
Director
Computer Specialist
Operations Manager
Skills
Medical Devices
Fda
Iso 13485
Capa
Quality Assurance
Regulatory Requirements
Design Control
Quality System
Regulatory Affairs
Validation
Iso
Iso 14971
Cross Functional Team Leadership
Product Development
21 Cfr
Mdrs
Corrective and Preventive Action
Management
Process Improvement
Gmp
U.s. Food and Drug Administration
Iso Standards
R&D
V&V
Product Launch
Project Management
Six Sigma
Fmea
Root Cause Analysis
FAQs about Darren Demerritt
What's the main profession of Darren Demerritt?
The expert is a Director of Regulatory Affairs and Quality Assurance.
What are the profession of The professional?
These person's professions are IT Professional and Software Tester
Where does Darren Demerritt live?
The expert currently lives in Bothell, Washington.
What is Darren's email?
Darren Demerritt's email is dl**@gmail.com and da**@physio-control.com.
How many companies did Darren Demerritt work at?
Darren Demerritt worked at six jobs.
What education does Darren Demerritt have?
Darren studied at the Eastern Washington University from 2001 to 2005.
What is the industry that Darren Demerritt worked in?
Darren Demerritt works in Medical Devices industry.
What are professional skills of Darren Demerritt?
This person has such skills as Medical Devices, Fda, Iso 13485, Capa, Quality Assurance, Regulatory Requirements, Design Control, Quality System, Regulatory Affairs, Validation, Iso, and Iso 14971.