Medical Director, Patient Safety and Compliance

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 114,000 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

This position: Medical Director, Patient Safety and Compliance, works out of our Lake Forest, IL location in the Infectious Disease Business Unit in Abbott Rapid Diagnostics. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

What You’ll Work On

This position will manage Patient safety to provide medical risk and sexual transmitted diseases (STD) guidance for the business group, including support to maintain focus on product performance and safety, product/program development and customer education. The director hired will work cross functionally to support lateral flow technology (LFT) in sexual transmitted diseases (STD), and provide input to establish the STD LFT range plans and goals for Medical Affairs, and is responsible for the implementation and maintenance of the Patient safety-related medical assessments.

This role provides leadership and direction to product performance testing and evaluation, use clinical and medical experience and knowledge in the area of patient safety and risk management activities, and they serve as an advisor to support publications, abstracts and presentation and cross-functional needs of STD. This director provides medical leadership for product and clinical product performance functions including monitoring and reporting of product safety related items (i.e. complaints, vigilance, MDRs), development and modification of risk management documents such as FMEA, Hazard Analysis and Health Hazard Evaluations (HHE). This includes providing critical direction in establishing and implementing required product safety and medical education processes and procedures for new products and technologies as clinical studies are implemented, worldwide regulatory approvals are obtained, and products are commercialized.

In addition:

Direct the design, planning, development and monitoring of all medical risk management, including risk analyses, health hazard evaluations, failure modes and effects analyses.

Participates in the Risk Analysis process for new or improved devices to ensure that potential risks to patients associated with use of the device are identified and appropriately analyzed.

Take the lead role in the development of risk management input for FMEA, HHE and other risk related documents.

Prepare medical platform documents and medical opinions to support product development

Contributes medical perspective to the decision making process regarding product recall or field action by attending meetings with the Product Action committee, summarizing clinical feedback, performing product testing as needed and providing general clinical knowledge and expertise

Responsible for having superior leadership and coaching skills to build relationships throughout the Division (particularly with R&D and QA/RA) and motivate the Patient safety team.

Provides medical support in STD area that includes representing the Division at Medical Conferences, Sales Meetings and Physician/Hospital interactions, conveying com