Senior Regulatory Affairs Associate

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


The Senior Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system. Development of regulatory documents; planning, tracking, execution, and archival of regulatory submissions; performing regulatory landscape; and regulatory affairs project management in support of designated activities.


Duties & Responsibilities:

  • Generate audit agenda, plan, summary report, and perform internal/external audits.
  • Planning, managing, and tracking successful FDA submissions.
  • Coordinate and support management of external audit scheduling.
  • Support management of supplier qualification program.
  • Initiate, review, and investigate quality events.
  • Perform FDA/AATB reportability determination for quality events.
  • Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Prepare regulatory documents for FDA/AATB for reportable events.
  • Assist with regulatory submissions for TRG letters, Request for Designation (RFD), and Pre-RFD.
  • Complete submission/update of FDA registrations.
  • Complete state license application submissions and renewals.
  • Support development of validation protocols to verify compliance with regulatory requirements.
  • Review validation protocols to verify compliance with regulatory requirements.
  • Support new projects and product development.
  • Monitor regulatory updates.
  • 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 multi-task.
  • Effective verbal and written communication skills.
  • Ability to work independently and in a team environment.


Education & Experience:

  • Bachelor’s degree in biological science or related field required.
  • Minimum 5 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field).