Quality and Regulatory Manager

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 21

CFR
820 and ISO
13485:2016, Working knowledge of 21

CFR
1271 and the AATB Standards of Tissue Banking is a plus.

• 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

• 3+ years of relevant work experience
• Experience with in 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