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Senior Medical Events Specialist

Abbott Laboratories

This is a Contract position in Baton Rouge, LA posted December 2, 2021.

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 109,000 colleagues serve people in more than 160 countries.

About Abbott Diagnostics Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health.

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life.

Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our location in Lake Forest, IL, currently has an opportunity for a Senior Medical Events Specialist.

The primary function of this role is to comply with relevant US and International regulatory requirements through the timely review; documentation; and filing of global ADD medical complaints.

Ensure the safety and effectiveness of products in the field by interfacing with other functional areas (e.g.

Customer Service and Site Quality) responsible for complaint handling and evaluations and highlighting potential medical; clinical and/or safety issues with ADD products.

Ensure that non-conformances or potential non-conformances in the medical event reporting process are identified; documented; and resolved through effective CAPA implementation and monitoring.

Lead initiatives for continuous process improvements.

Position is accountable for making medical device reportability decisions and preparing clear; accurate; and timely medical event reports to be submitted directly to regulatory authorities.

This position is responsible for global compliance of medical device reports submitted to US and International Authorities.

WHAT YOU’LL DO Responsible for implementing and maintaining the effectiveness of the quality system.

Review medical complaints; document filing decision rationale; and submit medical event reports in compliance with FDA regulations and International Regulatory requirements within the required timeframes.

Ensure medical event file documentation is clear; concise; and adheres to compliance requirements.

Identify any non-conformances or potential non-conformances in a timely manner; ensure thorough documentation; and aid in the development of comprehensive CAPA strategies to prevent recurrence.

Provide subject matter expertise and training; as needed; to other functional areas (e.g.

Customer Service and Support and Quality) responsible for identifying and resolving potential medical; clinical and /or safety issues.

Lead projects or initiatives to improve the compliance and/or efficiency of the medical event reporting process.

Interface with senior management and other functional areas, as required, to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis.

The above statements are intended to describe the general nature and level of work being performed; other duties may be performed as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING Required Bachelor’s Degree or Clinical Laboratory / Medical Technologist experience Minimum of 6 years combined experience as a medical event specialist, a medical technologist in a clinical laboratory setting, and/or a strong technical role (Technical Support, complaint handling, etc.) with ADD products is required.

Preferred Bachelor’s degree with preference in a technical scientific discipline or an equivalent combination of education and work experience Working knowledge of the ADD complaint handling process is strongly preferred RN, BSN, or Medically trained professional with knowledge of FDA/International guidelines for drug/medical device safety reporting requirements Knowledge of FDA/International guidelines for drug/device safety reporting requirements Working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience Medical Technologist experience with Medical Technologist Certification (e.g.

ASCP; AMT; MLT; or similar) WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.

We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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