Regulatory Affairs Manager

Position Title: Regulatory Affairs Manager
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 managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system.

Duties & Responsibilities:

  • Review and approve audit agenda, plan, summary reports for internal audits.
  • Facilitate and participate in external audits and collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
  • Manage and oversee supplier management program.
  • Initiate and investigate quality events.
  • Perform FDA/AATB reportability determination for quality events.
  • Review and approve quality events, ensuring appropriate investigation and CAPA.
  • Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Manage submissions of FDA/AATB reportable events.
  • Manage state license application submissions and renewals.
  • Manage unique device identifiers (UDI) submissions and renewals.
  • Manage and lead regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, etc.
  • 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 and evaluate need for procedural changes to ensure compliance.
  • 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.
  • Manage direct reports.
  • Establish and monitor objective annual goals for direct reports.
  • Conduct performance reviews and establish performance improvement plans as needed.
  • Establish and execute continuing education strategy for department.
  • Recruit, interview, and select personnel for hire.
  • Attend/participate in offsite business meetings/conferences.
  • Perform other related duties as assigned.

Skills & Abilities:

  • Extensive knowledge of applicable government regulations. 
  • Ability to inform and educate department heads on regulations and policies that require compliance. 
  • Excellent attention to detail and organizational skills
  • Ability to multi-task
  • Effective and verbal communication skills. 
  • Strong Leadership skills.

 Education & Experience:

  • Bachelor’s degree in a biological science or related field required.
  • Master’s degree preferred.
  • At least 5 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management responsibilities/experience.