Postmarket Surveillance Manager

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. Youll 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 bachelors 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 Youll 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.

Essential Duties and 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

Required Qualifications:

• Bachelors Degree in Statistics Mathematics Engineering Science or other technical discipline
• 6 years experience in quality systems complaint handling regulatory reporting (or 4 years with Masters)
• 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.

Specifications/Other:

• Physical abilities (must be able to lift 50 lbs.)
• Mental abilities (Use a computer 8 hours per day)
• Working Conditions (Regular office environment; require the ability to sit stand and work at a desk)

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

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Manager