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Quality Assurance and Regulatory Affairs Manager

Company Name: FaceMaster of Beverly Hills, Inc.
Location: Beverly Hills, CA
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: Commensurate with experience (health plan provided)

Job Description

The FaceMaster Quality Assurance and Regulatory Affairs Manager is responsible for the successful establishment, maintenance and regulatory compliance for a small medical device company. This position will take the lead role in maintaining and improving the QMS, including all procedures, instructions and forms necessary to demonstrate compliance with CA state and federal regulations. Additionally, this position will be responsible for the successful completion of regular internal audits as well as hosting regulatory inspectors during any regulatory inspection of records or facilities. 

Responsibilities: Support the existing quality management system (process monitoring, complaint handling, document controls, etc.), training, internal audits, act as Management Representative, host regulatory inspections. 

The individual in this position will also be expected to participate in local regulatory professional groups (for instance, RAPS and OCRA) and maintain competency in 21CFR820 and 21CFR803, as well as other federal and/or state regulations that FaceMaster must be compliant with.

Job Requirements 

  • Knowledge and competency in 21CFR820, 21CFR803 and Universal Device Identification (UDI)
  • Education: BSEE/ME or science degree and at least 5 years’ experience establishing and maintaining a Quality Management System
  • Good communication skills
  • Ability to work independently and in a team environment. 

Please forward cover letter and resume to This email address is being protected from spambots. You need JavaScript enabled to view it.

 

 

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