With work experience over 25 years, Dan Hoefer is nowadays working at Chemence Medical Products which is situated in 5 as a Director of Regulatory Affairs and Quality Assurance. Dan received his education from 1980 to 1987 at the University of Utah. Dan Hoefer is located in Atlanta, Georgia. To contact Dan, you can look for their phone or e-mail address or find full info by requesting access to this professional's additional details.
Name variants:
Daniel Hoefer
Last updated May 01, 2024
Contact Information
Last Update
Jul 10, 2022
Email
da**@bellsouth.net
Location
Atlanta, GA
Company
Workplace
Director of Regulatory Affairs and Quality Assurance
Alpharetta, GA
Industry
Medical Devices
Colleagues
Work History
Director of Regulatory Affairs and Quality Assurance
200 Technology Dr, Alpharetta, GA 30005
Lead Quality Systems Management, act as management representative, internal and external auditing, supplier auditing, process validation, design controls, ISO 13485:2016 transitioning, globa...
from Jan 2018
Senior Manager Regulatory Affairs
11810 Wills Rd, Alpharetta, GA 30009
Management of regulatory organization, global med device clearances and registrations, compliance of regulated medical devices, risk management, medical device reporting and vigilance, audit...
Apr 2013 — Dec 2017
Manager, Regulatory Affairs
150 Verona St, Rochester, NY 14608
Global Regulatory Affairs management, manage Quality Management System for Medical Device Company, management representative, management review leadership, Radiation Safety program developme...
Feb 2004 — Mar 2013
Regulatory Engineer
41 Farnsworth St, Boston, MA 02210
FDA compliance, 510(k) authorship, recall coordination, X-ray system compliance, site radiation safety, Class III device clearances for Canada, test method development, complaint investigation
May 2001 — Feb 2004
Regulatory Affairs Manager
Held several roles including Sales Engineer, Sales & Service Manager, and Regulatory Affairs Manager for laser system manufacturer
Sep 1992 — May 2001
Education
1980 — 1987
1980 — 1984
Occupations
IT Professional
Software Tester
Executive
Director
Representative
Sales Specialist
Supplier
Senior Manager
Master of Education
Computer Specialist
Operations Manager
Services Professional
Sales Representative
Skills
Medical Devices
Quality Assurance
Management
Fda
Regulatory Affairs
Team Building
Leadership
Cross Functional Team Leadership
Business Process Improvement
Software Documentation
Design Control
Capa
R&D
Regulations
Iso 13485
Six Sigma
Quality System
Product Launch
Process Improvement
Product Development
510 K