Quality Assurance and Regulatory Affairs

The job role has responsibility for driving Quality Assurance and Regulatory Affairs across the organization of Diagnostics/Reagents. This is a hands-on transformative and strategic management position with a high impact on the organization.

• For Reagents the primary focus will be to develop, implement, and coordinate product assurance programs for contract manufacturing of products, reagents and materials in the cancer diagnostics arena.
• For Diagnostics as a whole, the focus will be to develop, implement, and coordinate product assurance programs for in vitro diagnostic kits manufactured for our company by a contract manufacturer and supplied directly to customers internationally and eventually domestically.

The position will serve as regulatory contact with European Competent Authorities and other regulatory agencies in matters of European IVD product registrations and licensing.

Many key tasks will apply to both activities:
• Provides guidance and assistance with the development of validation plans and protocols. Reviews and approves protocols and final validation reports.
• Develops and maintains a robust supplier qualification program that aligns with recommendations of the Global Harmonization Task Force.
• Reviews complaint, servicing, internal audit and external audit reports. Ensures that appropriate actions (including investigations) are initiated in response to findings.
• Provides regulatory guidance and support to project teams and Sales/Marketing for clinical and performance trials.
• Develops coordinated metrics programs, identifying the appropriate statistical methods for analyzing system data and ensures quality statistics are reported to Senior and Corporate Management teams in a timely manner.
• Aligns quality and regulatory activities with Corporate Quality Objectives.