For The Candidates

Ra Dr Qa Regulatory Affairs Director Quality Assurance - Device
AZ
Type: Full-Time
Category: Regulatory Affairs
Job ID: 774
Opportunity Description:

(520) Area Code          AZ                                   Salary 100k-110k

Regulatory Affairs and Quality Assurance Director

As the DIRECTOR OF RA/QA you would be a vital part of a dedicated and innovative team of professionals who strive to "make people better faster."

Responsibilities

  • Advises and keeps management team updated on regulatory issues, trends and events in outside environment that could impact the company
  • Develops and implements procedures to ensure regulatory compliance
  • Develops and implements new product submissions to regulatory bodies
  • Hosts outside regulatory agencies
  • Responsible for planning and directing quality assurance policies, programs, and initiatives
  • Participates in the development of a strategic plan to define the company business direction into the future
  • Leads a team of people, ensuring their growth and development and their ability to meet MRI performace standards

Required:

  • Applicable Bacelor's degree with a minimum of 10 years directly related experience
  • Knowledgeable in FDA Requirements for medical device manufacturers or experience with medical devices/pharmaceuticals
  • Experience in working with top level management
  • Solid strategic and analytical skills

Preferred:

  • MBA or other advanced degree
  • Medical device and pharmaceutical background
Packaging and Sterilization Experience
 
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