Abbott is looking to solve problems related to medical device regulatory reporting, product quality, regulatory compliance, and customer satisfaction within their Electrophysiology (EP) division. They need to ensure timely and accurate submissions to regulatory authorities, provide expert clinical and technical support, and drive continuous improvement in clinical support processes.
Requirements
- 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.
- Strong analytical skills with the ability to evaluate complex devices and data.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Prior CAPA experience is a PLUS
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.
- Review product manuals and communications for clinical and technical accuracy.
- Develop, implement, and evaluate Corrective and Preventative Action (CAPA) plans.
Other
- 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.
- 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.
- Leadership experience or ability to mentor team members.
