JOB DESCRIPTION:

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 technologically complex devices is required. Demonstrated ability to formulate a risk assessment profile and potential clinical interventions; a proven ability to qualitatively assess the impact of changes in clinical policy and technical recommendations as they pertain to potential product notifications, potential litigation and patient safety.
• Documented record of delivering information that adds value to management's decision making process. Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.
• Advanced evaluation skills, originality and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential; the ability to understand and comply with applicable U.S. FDA regulations and Company operating procedures, processes, policies, and rules is also required. Demonstrated personal computer skills including spreadsheet skills, word processing, database management and other relevant project management applications. Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.

Preferred Qualifications

• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable. Ability to travel approximately 5-25%, including internationally.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

The base pay for this position is
$99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
HF Heart Failure

LOCATION:
United States > Massachusetts > Burlington : 168 Middlesex Turnpike

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 15 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)