Director, Quality Assurance and Regulatory Affairs

About Meridian

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 that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision.

Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

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

Tasks/Duties/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, where applicable, 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.
  • 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 implements plans consistent with 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, ensure team’s work is done effectively, accurately and on time.
• Recruit, hire, on‑board, mentor and develop talent to build a high performing and effective team.
• Other duties as assigned.

• 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; experience regarding medical device design, development and manufacturing regulations,…