Postmarket Surveillance Manager

Abbott • Saint Paul, MN

1d

About The Position

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: Job Title Post-Market Surveillance Manager Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 of which you dream. 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity We currently have an opening for a Post-Market Surveillance Manager for the Vascular division. This role can be located at our St. Paul, MN location. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. What You’ll Do: Manage a post-market surveillance team that executes the complaint investigation process for devices. Post market surveillance processes and activities are mainly related to Complaint Investigations, Medical Device / Vigilance reporting, metrics monitoring and supporting external audits/inspections.

Requirements

• Bachelor’s Degree in Statistics, Mathematics, Engineering, Science or other technical discipline
• 6+ years' experience in quality systems, complaint handling, regulatory reporting (or 4+ years with Master's)
• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169
• Experience working in a regulated environment
• Experience managing and leading a team or acting as a lead to resolve issues
• Demonstrated critical thinking skills focused on improved system performance outcomes and positive impact
• Excellent problem-solving skills; demonstrated application of structured problem-solving methods and tools
• Technical writing and presentation skills.

Responsibilities

• Manages a team of contributors on post market surveillance activities. This includes the investigation of product malfunctions, product design and/or labeling problems, as well as customer dissatisfaction issues, and the regular monitoring and reporting of complaint handling status and metrics.
• Monitors metrics and drives process improvements based on performance trends
• Drive product quality improvements and support quality-based processes to ensure the highest quality of products and solutions as well as compliance with all applicable regulations and requirements
• Collaborate with business partners to share feedback in order to improve product performance
• Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions as required.
• Initiate and facilitate corrective or preventative actions as needed
• Ensure quality customer and regulatory communications for current products
• Manage issues where analysis of situations or data requires an in-depth knowledge of organizational objectives
• Support and participate in internal and external audits, risk management summaries, health hazard evaluations
• Prepare and provide monthly reports to trend key quality measures as part of the corrective and preventive action (CAPA) system.
• Provide mentoring to Quality teams members to ensure growth
• Working with Quality, Marketing, Product Development, Clinical and Regulatory on post market surveillance reports.
• Work directly with customers on issues, as needed

Benefits

• Career development with an international company where you can grow the career of which you dream.
• 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager