Regulatory Affairs Manager

2 months ago


San Antonio, United States KYDA Partners Ltd Full time

The KYDA Partners team is seeking a Regulatory Affairs Manager to lead and manage the regulatory affairs department, ensuring compliance with regulatory standards and the quality management system.


Key Responsibilities:


  • Internal Audits:
  • Review and approve audit agendas, plans, and summary reports.
  • External Audits:
  • Facilitate and participate in external audits.
  • Collaborate with Quality Assurance Management to generate audit responses and associated Corrective and Preventive Actions (CAPAs).
  • Quality Management:
  • Support Failure Mode and Effects Analysis (FMEA) of existing products and procedures.
  • Initiate and investigate quality events.
  • Manage and oversee the supplier management program.
  • Perform FDA/AATB reportability determinations for quality events.
  • Review and approve quality events, ensuring appropriate investigations and CAPAs.
  • Author and revise procedures according to FDA, AATB, and other relevant regulations.
  • Manage submissions of FDA/AATB reportable events.
  • Manage state license application submissions and renewals.
  • Stay updated with regulatory changes and evaluate the need for procedural updates to ensure compliance.
  • New Product Realization:
  • Support and collaborate with the New Product Realization Regulatory Affairs team.
  • Regulatory Knowledge:
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and other relevant regulations and industry standards.
  • Record Management:
  • File and maintain records according to standard operating procedures.
  • Team Management:
  • Manage direct reports and establish annual objectives.
  • Conduct performance reviews and implement performance improvement plans as needed.
  • Develop and execute a continuing education strategy for the department.
  • Recruit, interview, and select new personnel.
  • Professional Development:
  • Attend and participate in offsite business meetings and conferences.
  • Perform other related duties as assigned.
  • Support cross-functional Regulatory Affairs tasks when needed.


Education & Experience:


  • Bachelor’s degree in a biological science or related field required.
  • Master’s degree preferred.
  • Minimum of 5 years of quality and/or regulatory experience in an FDA-regulated environment for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and/or medical devices, with progressive management responsibilities.



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