Director, Quality Assurance and Regulatory Affairs

Meridian Bioscience, Inc.•Billerica, MA

About The Position

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.

Requirements

Bachelor’s Degree in Biological Science, Engineering or Health Sciences required.
At least 10 years’ experience leading in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, specifically 21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, as well as ISO 13485 requirements.
At least 5 years’ experience in Vitro Diagnostic device.
Must have experience with applying ISO 14971 principles to medical devices throughout all stages of the product’s lifecycle.
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.
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, projects are completed on time to meet growth objectives.
Adjusts easily and readily to a fast-paced work environment.
Demonstrates strong leadership, talent development, ability to work with single or multiple departments; demonstrated project management capabilities.
Knowledge of technical standards, including IEC 60601, IEC 61010, IEC 62366 for establishing the safety and effectiveness of medical electrical equipment.
Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
Knowledge of cGMP/QSRs, FDA device regulations, ISO 13485.
Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics.
Demonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, 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 setting.

Nice To Haves

Master’s Degree preferred.
Professional certification (RAC/ASQ) preferred.
Experience with statistical charting preferred.
Experience with ERP systems, electronic document management systems preferred.
Experience with electro-mechanical device development and software device design.

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, distribution management, product labeling, quality training programs, quality engineering, change control, document control, and continued development of the electronic document and record control system.
Ensure 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.
Manage change 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.