Group Lead Clinical Product Performance at Abbott

Plymouth, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in nursing, biomedical engineering, or a related science/engineering field
Minimum 5 years of experience in the medical field (incomplete in description)

Responsibilities

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

Skills

Key technologies and capabilities for this role

ElectrophysiologyClinical Product PerformanceRegulatory ComplianceProduct Quality AssuranceMedical DevicesStakeholder ManagementHealthcare Compliance

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this position remote or onsite?

This position works out of the Plymouth, MN location in the EP Division and requires onsite work.

What are the key responsibilities or skills needed for this role?

Key responsibilities include filing medical device regulatory reports with agencies like the FDA, providing clinical and technical information to healthcare professionals and teams, assessing literature for complaint decisions, interfacing with engineering on product development, leading complaint trending analysis, and conducting clinical and quality training.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What is the salary for this position?

This information is not specified in the job description.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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