Abbott
Overview
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: The Opportunity
This position works out of our Plymouth, MN location in the EP (Electrophysiology) Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Group Lead Clinical Product Performance, you will serve as a key clinical and technical resource, providing expert support to healthcare professionals, internal teams, and global stakeholders. You will lead initiatives that ensure product quality, regulatory compliance, and customer satisfaction, while driving continuous improvement across clinical support processes. In this role, you will also be responsible for performing medical device regulatory reporting in accordance with global regulatory guidelines, ensuring timely and accurate submissions to regulatory authorities. What You’ll Work On
Independently determining and filing appropriate medical device regulatory reports with various regulatory agencies and worldwide governing bodies, including but not limited to the FDA. Provide clinical and technical information in response to inquiries from healthcare professionals, patients, and internal teams. Assess published literature for product-related complaint/reportability decisions. Interface with engineering teams on new product development, launches, and sustaining efforts. Lead or contribute to complaint trending analysis, including preparation of charts and reports using complaint databases. Conduct and deliver clinical and quality training to internal personnel. Review product manuals and communications for clinical and technical accuracy. Develop, implement, and evaluate Corrective and Preventative Action (CAPA) plans. Collaborate with international teams to resolve global product and clinical issues. Support audits through direct interaction with auditors and internal teams. Stay current on regulatory requirements and industry standards, contributing to internal knowledge sharing. Promote continuous quality improvement and risk management practices. May lead a team or mentor others, depending on business needs. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Qualifications
Required Bachelor’s degree in nursing, biomedical engineering, or a related science/engineering field. Minimum 5 years of experience in the medical device industry or cardiac clinical setting. Strong analytical skills with the ability to evaluate complex devices and data. Excellent communication, presentation, and interpersonal skills. Proven ability to collaborate across departments and with external stakeholders. Experience working in a matrixed and geographically diverse environment. Ability to manage multiple priorities and meet deadlines. Prior Regulatory Reporting Experience Preferred Experience in cross-division business unit models. Detailed understanding and working knowledge of US and International regulations including 21 CFR, as well as the Medical Device Directive and EU MDR. Leadership experience or ability to mentor team members. Prior CAPA experience is a PLUS The base pay for this position is
$75,300.00 – $150,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Engineering
DIVISION:
EP Electrophysiology
LOCATION:
United States > Minnesota > Plymouth : 5050 Nathan Lane N
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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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: The Opportunity
This position works out of our Plymouth, MN location in the EP (Electrophysiology) Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Group Lead Clinical Product Performance, you will serve as a key clinical and technical resource, providing expert support to healthcare professionals, internal teams, and global stakeholders. You will lead initiatives that ensure product quality, regulatory compliance, and customer satisfaction, while driving continuous improvement across clinical support processes. In this role, you will also be responsible for performing medical device regulatory reporting in accordance with global regulatory guidelines, ensuring timely and accurate submissions to regulatory authorities. What You’ll Work On
Independently determining and filing appropriate medical device regulatory reports with various regulatory agencies and worldwide governing bodies, including but not limited to the FDA. Provide clinical and technical information in response to inquiries from healthcare professionals, patients, and internal teams. Assess published literature for product-related complaint/reportability decisions. Interface with engineering teams on new product development, launches, and sustaining efforts. Lead or contribute to complaint trending analysis, including preparation of charts and reports using complaint databases. Conduct and deliver clinical and quality training to internal personnel. Review product manuals and communications for clinical and technical accuracy. Develop, implement, and evaluate Corrective and Preventative Action (CAPA) plans. Collaborate with international teams to resolve global product and clinical issues. Support audits through direct interaction with auditors and internal teams. Stay current on regulatory requirements and industry standards, contributing to internal knowledge sharing. Promote continuous quality improvement and risk management practices. May lead a team or mentor others, depending on business needs. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Qualifications
Required Bachelor’s degree in nursing, biomedical engineering, or a related science/engineering field. Minimum 5 years of experience in the medical device industry or cardiac clinical setting. Strong analytical skills with the ability to evaluate complex devices and data. Excellent communication, presentation, and interpersonal skills. Proven ability to collaborate across departments and with external stakeholders. Experience working in a matrixed and geographically diverse environment. Ability to manage multiple priorities and meet deadlines. Prior Regulatory Reporting Experience Preferred Experience in cross-division business unit models. Detailed understanding and working knowledge of US and International regulations including 21 CFR, as well as the Medical Device Directive and EU MDR. Leadership experience or ability to mentor team members. Prior CAPA experience is a PLUS The base pay for this position is
$75,300.00 – $150,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Engineering
DIVISION:
EP Electrophysiology
LOCATION:
United States > Minnesota > Plymouth : 5050 Nathan Lane N
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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