Director, Medical Events Group & NPR - Abbott Diabetes Care

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 114000 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 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 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 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
The Director of the Medical Events Group (MEG) and No Product Return (NPR) will lead global medical device vigilance post-market surveillance and regulatory reporting for Abbotts Diabetes Care products. This role ensures worldwide compliance with FDA ISO 13485 EU MDR and other global regulatory standards. The Director will provide strategic leadership oversee medical event reporting processes and act as a key representative during regulatory inspections and audits. Additionally this role will oversee the No Product Return Investigation Team ensuring timely and thorough investigations for cases where product returns are not available.

What Youll Work On
Define and implement global medical device reporting and vigilance strategies for Abbott Diabetes Care.
Develop and enforce policies for capturing and documenting reportable events to comply with global requirements.
Ensure adherence to CFRISO 13485 and other international standards.
Oversee timely and accurate global filing of reportable events (FDA Health Canada MHRA EU MDR ROW).
Evaluate product safety issues highlight risks to senior management and drive mitigation actions.
Provide leadership during regulatory audits and inspections (FDA ISO etc.).
Lead and develop the Medical Events Group team fostering a culture of compliance and continuous improvement.
Manage the No Product Return Investigation Team to ensure robust Device History Review (DHR) and documentation for non-returned product cases.
Establish and maintain quality metrics to enhance process efficiency and data reporting.
Represent Abbott in external regulatory discussions and standard-setting activities.

Required Qualifications:
Bachelors or Masters in a scientific medical or technical discipline.
Minimum 810 years of experience in Quality Systems Regulatory Affairs or Quality Assurance within the medical device industry.
At least 5 years of leadership experience managing teams and complex regulatory processes.
Expertise in global medical device reporting regulations (FDA MHRA Health Canada EU MDR etc.).
Strong verbal and written communication skills at all organizational levels.
Proficiency in Microsoft Office Suite and familiarity with regulatory reporting systems.

Preferred Qualifications:
Prior experience in medical event reporting or post-market surveillance.
Advanced knowledge of global vigilance requirements and risk management frameworks.

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.

Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal

The base pay for this position is

$169300.00 $338700.00

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

JOB FAMILY:

Operations Quality

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Alameda : 2901 Harbor Bay Parkway

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Director