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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.

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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]