Regulatory and Quality Systems Manager, IVD

Regulatory and Quality Systems Manager, IVD

Talentry is looking for a professional Compliance Manager who can manage the quality management systems and ensure continued compliance. The right person will develop and implement the quality systems, lead audits, and author and edit key documents (processes, procedures, SOPs, reports, quality findings, etc.) required for the development, approval, and manufacturing of IVDs.

The right person will have experience with quality systems and FDA compliance including Production Process Controls, Supplier Management, Post-Marketing Surveillance, Document Control, and Quality Events Management (including CAPAs and NCRs) for IVDs in a cGMP environment.

Requirements

BS and 5+ years of experience.

Proven experience with Quality Systems in an IVD environment.

Solid organizational and documentation skills.

Demonstrated excellent communication skills.

Previous Document Management System experience (MasterControl, Qualio, etc.)

Proven ability to work cross-functionally, both internally and externally, and at all levels.

Benefits