The client is in search of a Quality and Regulatory Manager to join our growing team, responsible for the management and execution of day to day Quality and Regulatory systems. This position is a critical team member and will work collaboratively to ensure patient safety, product effectiveness, and quality/regulatory compliance.

IDEAL CANDIDATE:
The ideal candidate can work independently, has strong cognitive abilities, and 5+ years experience in Quality Assurance and/or Regulatory Affairs in a Medical Device or Human Tissue company. They must be able to own, develop, and manage Quality/Regulatory systems with minimal oversight and must have working knowledge of 21CFR820 and ISO13485:2016, Working knowledge of 21CFR1271 and the AATB Standards of Tissue Banking is a plus.

KEY RESPONSIBILITIES:
  • Manage and execute daily QA and Regulatory activities including Change Control, Document Control, Deviations/Non-Conformances, CAPAs, Supplier Management
  • Ensure the timely documentation, execution, and completion of quality records
  • Support regulatory (FDA, ISO) and customer audits
  • Support ongoing and new projects from a Quality/Regulatory perspective
  • Provide record review and Quality release of Sterilization and Finished Goods
  • Manage renewal of Regulatory registrations and licensing
REQUIREMENTS:
  • 3+ years of relevant work experience
  • Experience within Quality and Regulatory in a regulated life sciences company (Medical Device, Biologics, Pharmaceutical, or Human Tissue)
  • Ability to work independently
  • Effective time and project management skills
  • Technically proficient
  • Experience working in electronic Quality Management Systems
  • Ability to support supplier audits a plus

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