Product Performance Clinical Lead
$78,000–$156,000 year
On-sitePlymouth, Minnesota, United States
Job Summary
Serve as the clinical and technical interface between the medical community and the Product Performance Group, applying expertise to determine reportability of product complaints to global regulatory bodies like the FDA. Lead a small team of direct reports while maintaining a regulatory compliance program that reviews the complaint process routinely. Provide clinical, regulatory, and product training to staff and assist in drafting responses to inquiries from regulatory bodies, physicians, and field staff. Review complaint files to ensure compliance with internal processes and update procedure documents as needed. Exercise judgment in planning, organizing, and coordinating work while remaining abreast of medical advancements to communicate them to colleagues. This role involves a high degree of independence within Abbott's Electrophysiology and Heart Failure divisions, with approximately 5% travel required.
Required Qualifications
- Health Care Professional background
- Nursing
- Biomedical Engineering
- Knowledge of patient disease states related to the heart
- Ability to establish/maintain good working relationships and be able to work cooperatively/productively with various business partners, e.g., engineers, vendors, customers, field clinical engineers
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks
- Strong organizational and follow-up skills, as well as attention to detail
- Problem-solving
- Proficient computer skills
Desired Qualifications
- Experience in the Cath Lab, hospital setting or medical device
- Knowledge of U.S. Food and Drug Administration (FDA) regulations for medical device reporting
- Knowledge of global regulatory reporting requirements for medical device reporting
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