Senior Director, Quality Assurance & Regulatory Affairs

Location: Norcross, GA (Hybrid)

Overview:

We're looking for a dynamic and goal-oriented individual to lead our Quality division. In this pivotal role, you'll oversee the site's Quality system, guiding the Quality Assurance, Quality Control, and Regulatory Affairs teams.

Your responsibilities will encompass the development, implementation, and maintenance of a site Quality Management System that aligns with US Federal Regulations, EU Regulation 2017/746, EN ISO 13485 standards, and our own Quality criteria for manufacturing, controlling, storing, and distributing products. As a key member of the site leadership team, you'll champion a culture of Quality and Compliance, advocating for 'Right First Time' and Continuous Improvement principles while overseeing the GMP aspects of plant operations.

You'll collaborate with senior management to establish and enforce policies, ensuring they meet both our internal standards and regulatory requirements. Your role is critical in deciding the acceptability and release of all products from the site. Your oversight will extend to Quality Assurance, Quality Control, and Regulatory Affairs documentation, as well as liaising with regulatory inspections and customer audits. Additionally, you'll manage the department's budget, staff recruitment, and development, and steer the overall management of the Quality and RA teams.

Key Responsibilities:

• specialized knowledge and direction in understanding and applying government regulations, agency guidelines, and company policies to ensure adherence.
• and enforces policies and procedures to comply with relevant laws and regulations, also overseeing the fulfillment of regulatory reporting obligations.
• and maintains strategies for regulatory filings and market approvals, ensuring these align with product development and lifecycle management.
• with the comprehensive monitoring and successful operation of specified functions, integrating these seamlessly with other key organizational units.
• as the site's Management Representative and the Person Responsible for Regulatory Compliance (PRRC), as outlined by 21CFR part 820 and the In Vitro Diagnostic Regulation (IVDR) Regulation (EU) 2017/746.
• the strategy for risk management and design controls in the creation and production of new and existing Medical Device products.
• autonomously, steered by broad organizational policies and goals, making decisive choices that impact significant organizational components or functional activities.
• that tasks, including regulatory filings, CAPAs, investigations, and various compliance-related activities, are completed within set timelines.
• that employees within the relevant departments receive and document necessary training.
• manages, and adheres to the budget for the designated departments.

Minimum Requirements & Experience:

• of a Bachelor of Science degree or an equivalent qualification in a Science or Engineering discipline.
• least 10 years of leadership experience encompassing responsibilities in Quality Assurance and Regulatory Affairs within the In Vitro Diagnostics (IVD), Medical Device, and/or Biopharmaceutical sectors.
• track record of successfully navigating US FDA, EU, and Rest of World (ROW) pre-market audits/inspections and regulatory filings, including 510(k) submissions and IVDR/MDR compliance.
• in developing processes and systems that adhere to Quality System Regulations (QSR), including 21CFR Parts 210, 211, 11, and 820, as well as ISO 13485 and ISO 14971 standards, with a particular focus on Corrective and Preventive Action (CAPA) Systems.