Director, Regulatory Affairs and Quality Assurance

Employment Type

: Full-Time

Industry

: Executive Management



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Job Summary The Director of RA/QA is a key member of the senior leadership at Magellan Diagnostics, and is responsible for the successful operation of the company's quality and regulatory systems. The Director of RA/QA will act as the Management Representative. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities to ensure: The customer's experience and expectations for product quality & reliability are met and exceeded Established and emerging national and international quality regulations, standards and policies are met The company's quality system supports the corporation's strategic objectives and regulatory requirements Key Duties 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 efficacy; 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 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 Take action 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 department personnel to build a highly capable and effective team Participate in continuing education programs (self-study, seminars, etc.) to maintain currency of knowledge and apply new learning to the job Qualifications Education/Experience Bachelor's or Master's degree in a biological science, Engineering, or Health Sciences; Ph.D. preferred. 15+ years of experience in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, as well as ISO 13485 requirements. 5 years full time in vitro diagnostic device experience 5 years of experience managing supervisory personnel and contributing toward the development of department strategies Must have experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle. Working knowledge of technical standards, including IEC 60601, IEC 61010, IEC 62366 for establishing the safety and effectiveness of medical electrical equipment. Premarket Experience: 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. Postmarket Experience: Proven experience with recalls, corrections, removals, and MDRs required. Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner. Professional certification (RAC/ASQ). Skills, Specialized Knowledge and Abilities Able to use Microsoft Office, including Microsoft Word, Excel, PowerPoint, Outlook etc. Working knowledge of cGMP/QSRs, FDA device regulations, ISO 13485 Understands and can apply regulations and standards to new situations 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 Ability to communicate effectively both orally and in writing Previous experience with departmental budgeting, planning and management Previous experience with statistical charting Previous experience with ERP systems, electronic document management systems preferred Previous experience with electro-mechanical device development and software device design. Positive attitude, inspires others toward continuous quality improvement Demonstrated leadership skills Demonstrated team building skills Demonstrated ability to build commitment across a range of teams and at all levels of the organization, tactfully overcoming resistance; prepares and supports those affected by change 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 Requirements (Physical, Mental, Environmental Demands) Must be able to travel by air or car to perform audits, attend meetings as needed (percentage of travel varies). Must be able to wear personal protective equipment (gloves, face shields, etc) when on the manufacturing floorSalary Range: NAMinimum Qualification15+ years
Associated topics: automation, performance test, qa, quality assurance, quality assurance engineer, quality assurance lead, software quality, software quality engineer, software quality assurance engineer, tester

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