Regulatory Affairs Associate

Position Title: Regulatory Affairs Associate
Department: Quality Assurance
Reports To: Director of Quality Assurance & Regulatory Affairs
Job Type: Full Time
Shift: Monday - Friday 08:00 AM - 05:00 PM
Exempt / Non-Exempt: Exempt


The Regulatory Affairs Associate is responsible for assessing and supporting regulatory compliance of the quality management system.

Duties & Responsibilities:

  • Generate audit agenda, plan, summary report, and perform internal audits.
  • Assist with supplier qualification for vendors, customers, consultants, and other services (as appropriate).
  • Initiate and investigate quality events.
  • Assist with quality event reportability determination to FDA/AATB.
  • Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Support submissions of FDA/AATB reportable events.
  • Assist with state license application submissions and renewals.
  • Support development of validation protocols to verify compliance with regulatory requirements.
  • Support new projects and product development.
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.
  • File and maintain records in accordance with standard operating procedures.
  • Perform other related duties as assigned.

Skills & Abilities:

  • Excellent attention to detail and organizational skills. 
  • Ability to work independently & in a team environment.
  • Ability to multi-task
  • Effective verbal and written communication skills. 
  • Extensive Knowledge of applicable government regulations

Education & Experience:

  • Bachelor’s degree in a biological science or related field required.
  • At least 3 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field).