Manager of Quality & Regulatory Affairs

(Job Id W329493)
Posted on 3/5/2010
Location:

United States


Job Type:

Full Time


Salary: $90000.00 to $120000.00/year
Degree: Bachelor of Science
Job Description
This company is a privately held successful growing Medical Device manufacturing company located in the Midwest. This position will report to the CFO. The position responsibilites will be; Primary lead contact for all FDA Compliance, Class II Medical Device, CE Marking, 510 submissions and MDR control. Selected candidate will have experience in domestic and international regulatory registration. This position will manage the QA dept. will design and implement cGMP systems, conduct audits of internal departments, oversee customer complaints, incidents, deviations and failure investigations. Host FDA inspections. MUST HAVE QUALITY ASSURANCE BACKGROUND IN A MEDICAL DEVICE ENVIRONMENT AND MUST HAVE SUPERVISED individuals.