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Quality and Regulatory Manager

CEDENT

Hackensack, NJ

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JOB DETAILS
SKILLS
Banking Services, Biology, Biotech and Pharmaceutical, Change Control, Code of Federal Regulations, Document Control, Document Management, Documentation, FDA Requirements, ISO (International Organization for Standardization), Insurance Regulations, Licensing, Medical Equipment, Patient Safety, Product Safety, Project/Program Management, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Sterilization, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Management
LOCATION
Hackensack, NJ
POSTED
30+ days ago
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

About the Company

C

CEDENT