Job Description

Applied BioCode, an innovative manufacturer of diagnostic products for clinical lab and over the counter (OTC) markets, is searching for an exceptional Director of Quality Systems and Regulatory Affairs.

The position is located at the Corporate office in Santa Fe Springs, California and reports to the CEO.

General Purpose

Manage Quality activities related to all the company’s diagnostic products to ensure compliance with US FDA and European regulations/directives for product commercialization.

Responsibilities

• Quality
• Maintain an efficient and effective Quality Management System that meets QSR and ISO 13485:2003 standards, including CAPA, Complaint Management, Trending, Document Control, Change Control, Internal Auditing, Risk Management, Quality System Training, and Supplier and Non-Conforming Material Controls.
• Manage customer complaint, CAPA and trending processes
• Communicate with Executive Team on a regular basis inclusive of conducting and leading Management Reviews.
• Ensure processes are in compliance with current FDA & European Medical Device/In Vitro Diagnostic device regulations and directives, ISO 13485, 21 CFR 820 (QSR) and 21 CFR Part 11.
• Promote continual improvement. Review, modify, and implement new and revised quality system elements and controls.
• Support Product Monitoring in identifying and prioritizing complaint trends and high-impact customer issues.
• Ensure that all regulatory requirements are met for manufacturing and quality.
• Act as lead regulatory and quality representative during FDA and ISO/Notified Body audits.
• Regulatory experience in the following areas is a plus:
• Work closely with R&D and Clinical Affairs to ensure that validation study designs meet regulatory requirements. 
• Oversee the preparation and submission of marketing applications and routine regulatory registrations, reports and renewals. This includes US FDA establishment registration, device listings and submissions; CE Technical Files, CE self certifications, CE Notified Body submissions; and related interaction with regulators.
• Strategic
• Keep abreast of legislation, standards, guidelines, industry practices, and target country submission requirements.
• Perform special projects as directed by executive management.
• Management
• Manage assigned staff

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