20758 Sr. Director, Quality Assurance & Regulatory Affairs

20758 Sr. Director, Quality Assurance & Regulatory Affairs Atlanta, GA

Our client, a growing global supplier of specialty medical lab diagnostics is seeking a driven and results-oriented leader Sr Director QA / RA to join our Quality team.

In this role, you will be responsible for the site Quality System and leadership of the site Quality Assurance, Quality Control and Regulatory Affairs organization.

• Ensures that a site Quality Management System is established, implemented and maintained for product manufacturing, control, storage, and primary distribution processes in accordance with applicable US Federal Regulations, Regulation EU 2017 / 746, EN ISO 13485 standards and site Quality requirements.
• Act as the QA -RA representative of the site leadership team and, sponsoring Quality and Compliance-focused culture which embraces Right First Time and Continuous Improvement expectations and directing GMP aspects of plant activities.
• Interfaces with Executives and other top management personnel to set policy and to assure adherence to these, in addition to governmental standards.
• Responsible for the decision on acceptability and release of all site products.
• Organizational responsibilities include site Quality Assurance, Quality Control and Regulatory Affairs documentation, and regulatory inspection / customer audit liaison activities.

Additional responsibilities include site department budget, hiring and development of personnel, and management of the Quality and RA organization (5 MANAGERS 70-80 ee)

• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance
• Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met.
• Ensure regulatory filing strategies and market authorizations are developed and supported through product development and lifecycle management
• Ensure regulatory filing strategies and market authorizations are developed and supported through product development and lifecycle management
• Responsible for the overall surveillance and operation success of assigned functions and for successfully integrating these activities with those of other major organizational segments
• Serves as the site Management Representative and Person Responsible for Regulatory Compliance (PRRC), as defined by 21CFR part 820 the In Vitro Diagnostic Regulation (IVDR) Regulation (EU) 2017 / 746
• Directs the risk management and design control strategy for the development and manufacture of new and existing Medical Device products.

reagents, kits cloud software and diagnostic equipment)

• Acts independently, guided only by very broad company policies and objectives. Makes final decisions on administrative or operational issues affecting major segments or functional activities of the organization
• Ensures activities are completed within scheduled timeframes. (i.e. regulatory submissions / reports, CAPAs, investigations, MDRs / Vigilance / FSCA / complaint closure, etc.)
• Ensures adequate training (and documentation) of employees within the departments listed above
• Prepare, maintain and ensure adherence to departmental budgets.

Requirements

• B.S. Degree or equivalent in Science or Engineering.
• Minimum of 10 years in a management capacity covering a span of responsibility within Quality Assurance and Regulatory Affairs within the IVD, Medical Device and / or bio-pharmaceutical industry
• Demonstrated track record in successful US FDA, EU and ROW premarket audits / inspections and regulatory submission, including 510K and IVDR / MDR.
• Ability to establish processes and systems meeting Quality System Regulations (QSR), 21CFR Parts 210,211, 11, and 820, ISO 14385, ISO 14971 requirements and other related regulations with emphasis in CAPA Systems.
30+ days ago