Director, Quality Assurance and Regulatory Affairs

About the Company

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity, redefining the possibilities of life from discovery to diagnosis. Our innovative culture allows talented and passionate individuals to discover and create through collaboration, addressing tough problems with cutting-edge solutions.

About the Role

Responsible for the successful operation of Meridian’s quality and regulatory systems. Develop, implement, maintain, and improve the quality and regulatory systems for the site, integrating continuous improvement activities to ensure customer expectations for product quality and reliability are met. Ensure global quality regulations, standards, and policies are met.

Responsibilities

• Develop and implement global regulatory and compliance strategies to:
  • Ensure all products designed, manufactured, and/or shipped meet all regulatory, corporate, and customer requirements for quality, safety, and effectiveness.
  • Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post-market surveillance reports, import and export documents, safety testing, and other national and international requirements.
  • Optimize and focus on quality during the design and change control processes for both new and existing products.
  • Ensure all advertising and promotion materials conform to applicable FDA, FTC, and other country regulations.
• Provide operational leadership in planning and management of quality system activities, including:
  • Internal and external quality audits.
  • Measurement, analysis, and improvement programs, including quality trending.
  • Distribution management with respect to country licensure/registration.
  • Product labeling, including unique device identifiers and UDI databases.
  • Quality training programs.
  • Quality engineering (including testing, validations, verifications, investigations).
  • Change control and document control.
  • Continued development of the electronic document and record control system.
  • Ensuring costs associated with poor quality are captured.
• Formulate objectives and priorities and implement plans consistent with the long-term interests of the organization in a global environment.
• Capitalize on opportunities and manage risks, collaborating with Corporate QA/RA to share best practices and align where appropriate.
• Interface with external customers, FDA officials, and ISO assessors during audits and inspections.
• Make formal presentations to executive management, auditors, regulators, customers, and/or staff on quality-related activities.
• Act or generate alternative solutions to resolve complex quality or product problems.
• Foster the development of a common vision and fully participate in creating a unified leadership team that gets results.
• Change management with a focus on standards and compliance excellence, maintaining personal and department effectiveness during major policy, organizational, department, or team changes.
• Build effective working relationships with other departments to ensure timely completion of objectives and milestones, and to manage project- and team-related challenges.
• Plan, schedule, and manage department staffing and budget in accordance with the organization’s policies, department objectives, operation schedules, and key processes.
• Develop action plans with direct reports to ensure the continued success of the department, ensuring the team’s work is done effectively, accurately, and on time.
• Recruit, hire, onboard, mentor, and develop talent to build a high-performing and effective team.
• Other duties as assigned.

Requirements

• Bachelor’s Degree in Biological Science, Engineering, or Health Sciences required; Master’s Degree preferred.
• At least 10 years’ experience leading in the medical devices industry, with expertise in medical device design, development, and manufacturing regulations, specifically 21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, and ISO 13485 requirements.
• At least 5 years’ experience in Vitro Diagnostic devices.
• Experience applying ISO 14971 principles to medical devices throughout all stages of the product’s lifecycle.
• Professional certification (RAC/ASQ) preferred.
• Experience supporting medical device regulatory submissions (e.g., 510(k)s and/or PMAs); proven experience with application of quality and regulatory requirements in the design and development of medical devices.
• Experience with recalls, corrections, removals, and MDRs required.
• Experience with statistical charting preferred.
• Experience with ERP systems and electronic document management systems preferred.
• Experience with electro-mechanical device development and software device design.

Skills

• Able to solve complex quality, technical, managerial, or budgeting problems.
• Readily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks and projects are completed on time to meet growth objectives.
• Adjusts easily and readily to a fast-paced work environment.
• Demonstrates strong leadership, talent development, and ability to work with single or multiple departments; demonstrated project management capabilities.
• Knowledge of technical standards, including IEC 60601, IEC 61010, and IEC 62366 for establishing the safety and effectiveness of medical electrical equipment.
• Ability to work independently and identify or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
• Knowledge of cGMP/QSRs, FDA device regulations, and ISO 13485.
• Ability to build efficient quality assurance systems, including electronic document and record control, CAPA, NCR, complaint, training, and metrics.
• Demonstrated ability to write, review, execute, and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, and trend reports.
• Strong organizational and communication skills, covering written, spoken, and electronic communication types.
• Must be able to work independently as well as collaboratively in a team setting with peers and colleagues in a cross-functional environment.