Regulatory Affairs / Quality Assurance Associate

Title:                Regulatory Affairs / Quality Assurance Associate
Reports To:      Regulatory Affairs / Quality Assurance Specialist
Job Code:         5.3.1

Qualifications:  High school diploma or equivalent required. Bachelor’s degree preferred. Minimum of two years working in a quality environment. Experience in the Medical Device and/or Pharmaceutical Industry with an understanding of the FDA CGMP’s, ISO: 13485, 510(k) and CE preferred.

Essential experience and skills:

  • Quality orientation and high attention to detail.
  • Strong computer skills and high competency in applications such as MS Word, Excel, Outlook and Adobe Acrobat.
  • Excellent interpersonal and communication skills.
  • Experience working with high performance teams.
  • Problem analysis and problem resolution skills.
  • General knowledge of manufacturing processes.

Essential Duties and Responsibilities:

The RA/QA Associate will assist the RA/QA Specialist with administrative tasks associated with product and procedure compliance. Provide data management support with the ability to maintain great attention to detail and ability to multi-task.

Duties and Responsibilities also include:

  • Update and maintain complete and accurate regulatory compliance records including Complaint Tracking, CAPA, Employee and New Hire Training logs, Universal Device Identifier updates, marketing collateral, print change logs, etc.
  • Maintain organized files for all regulatory documents and data.
  • Assist with necessary procedural revisions
  • Assist with 510k submissions
  • Provide support on other RA/QA projects when necessary
  • Perform other duties as assigned

Physical Demands:

Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Must be able to sit for long periods of time.

Anticipated Travel: Less than 5%
 Position Status: Full Time
 Exempt Status:Exempt