Manager, Clinical Post Market Surveillance

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Working under broad supervision, manages the day-to-day compliance with applicable domestic and international regulations and activities related to complaint handling, Medical Device Report (MDR) submissions, and associated physician follow up, within an assigned facility. Provides functional management for the team, including goals, projects, feedback, coaching, and performance reviews. Identifies technical, tools, facility and other physical resources required by the team and obtains appropriate resources. Drives optimization and execution of business processes and tools related to complaint handling, submissions to competent authorities and related physician responses. Ensures appropriate complaint investigations are initiated and documented. Exercises independent judgment in planning and organizing work; monitors and drives performance and reports status. Assures that the quality of services meets internal and external customer requirements. Uses best business practices to ensure success in areas of assigned responsibility. Promotes the process of continuous quality improvement and coordinates solutions for technical and personnel issues. Resolves relatively complex regulatory problems and issues. Ensures employee compliance with product division policies, procedures and practices. What You’ll Work On • Accountable for the staff development; critiques, instructs, mentors, evaluates, and coaches. Accountable for the performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong customer focus. Models optimum leadership competencies to inspire an energized, empowered and accountable work force, ethical behavior, favorable community image, and actualization of the SJM Guiding Principles and product division management values. • Creates an environment that consistently fosters employee understanding of quality and motivates all employees to actively participate in the process of continuous quality improvement. • Oversees compliance with domestic and international regulations relative to the design and manufacture of medical devices for an assigned facility. • Trains or coordinates training for staff in product functionality, clinical conditions, department policies, other essential technical know-how and company policies. Responsible for quality and accuracy of information provided to regulatory bodies, internal stakeholders, and clinicians. • Ensures the investigation of all complaints and the generation of appropriate replies or reports as required by applicable regulations, before or by their due date. • Identifies and implements proactive strategies and metrics to ensure timeliness of reports to regulatory agencies and competent authorities. Seeks out and implements ways to accomplish higher quality deliverables, more efficiently. Tracks and ensures timely review of a high volume of reports and source documents. Reviews and approves medical device reports to ensure quality of reports. • May lead regulatory agency inspection activities, and escort regulatory and certification representatives through the facility. Provides information and reports as requested. • Maintains an awareness of, and disseminates information to management and staff on, all laws, regulations and nuances concerning quality assurance, manufacturing, and research and development that impact facility operations. • Collaborates with international country offices providing data, answers to questions, information for other countries’ competent authorities, metrics, and process enhancements. Responsibilities Provide leadership to maintain Quality Management System compliance for Abbott Heart Failure Atlanta. Oversee site’s compliance lifecycle, CAPA System and External Requirements Management System. Lead site’s CAPA program and drive continuous improvements by providing strategic direction for robust CAPA investigations and implementation of global resolutions while ensuring sustainability and effectivity. Manage External Requirements change impact assessment metrics and ensure changes to regulations, standards, Abbott policies etc are implemented timely. Serve as the primary interface with external regulatory bodies, manage internal and external inspections and overall audit strategies including any required responses concerning the site. Provide influential partnership to peers and strategic leadership to other functions within the site to define and implement an effective audit readiness program. Drive key readiness initiatives utilizing risk-based prioritization and mitigation to maintain an audit ready status. Evaluate and monitor the results of external and internal audits. Report the audit results to management and status/execution of corrective actions associated with the audit results. Analyze trends from various sources and proactively address regulatory, compliance, and quality issues. Actively participate in FDA inspections and lead internal/corporate audits, notified body audits and applicable external certification audits including any post-audit responses. Provide support for assessment of published regulatory guidance, changes to standards and Abbott policies to determine their impact and implement risk mitigation strategies at site or site level as applicable. Maintain an understanding of the business climate and relationships while implementing compliance improvement initiatives. Maintain quality excellence in all activities Maintain data analysis requirements for applicable Quality System metrics and Quality Management Reviews (QMRs). Lead, guide and retain a diverse, highly qualified staff and provide ongoing performance feedback. Set goals which align to business plans and manage the execution of goals through coaching and mentoring. Maintains a safe, enthusiastic, and professional work environment. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Required Qualifications Bachelor’s degree in biomedical engineering, Nursing or related academic field or an equivalent combination of education and work experience Progressively more responsible experience, including experience with medical devices. A minimum of three years of successfully managing a team. Strong skills in strategy, team management, and process enhancement (within the team, cross-functionally, and cross-divisionally). A demonstrated working knowledge of domestic and international regulations relative to the medical device industry is also desired. A demonstrated ability to analyze and evaluate technologic