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Summary
In this role, you will manage and oversee the recall process for healthcare products and devices. Ensure timely and effective communication, coordination, and resolution of product recalls within the healthcare organization. You will work closely with various departments and stakeholders to ensure compliance with regulatory requirements and patient safety standards.
Responsibilities
- Manage and oversee all aspects of the healthcare product recall process, including planning, execution, and resolution.
- Collaborate with cross-functional teams, including quality assurance, supply chain, regulatory affairs, and legal, to ensure a comprehensive and coordinated response to product recalls.
- Develop and maintain a recall management plan, including standard operating procedures, communication protocols, and escalation processes.
- Monitor and evaluate recall notifications from regulatory agencies, manufacturers, and vendors to identify affected products and develop appropriate action plans.
- Communicate recall information to internal stakeholders, including executives, department heads, and frontline staff, ensuring clear and concise instructions for implementation.
- Coordinate with external stakeholders, such as healthcare providers, distributors, and patients, to facilitate product recall procedures and provide necessary support and guidance.
- Conduct thorough investigations and root cause analyses to identify the source of the recall and implement corrective actions to prevent future occurrences.
- Maintain accurate and up-to-date documentation of all recall activities, including tracking, reporting, and documentation of outcomes and resolutions.
- Stay current with industry trends, regulations, and best practices related to product recalls in the healthcare sector.
- Collaborate with regulatory agencies, including the Food and Drug Administration (FDA) and other relevant authorities, to ensure compliance with regulatory requirements and reporting obligations.
Qualifications
- Relevant degree preferred.
- 5 or more years of relevant experience in healthcare administration, nursing, or a related field required.
- Proven experience in healthcare product recall management or a similar role within the healthcare industry.
- In-depth knowledge of regulatory requirements and guidelines related to product recalls, such as FDA regulations.
- Strong understanding of healthcare operations, supply chain management, and quality assurance processes.
- Excellent organizational and project management skills, with the ability to prioritize tasks and meet deadlines in a fast-paced environment.
- Exceptional communication and interpersonal skills, with the ability to effectively communicate complex information to diverse stakeholders.
- Strong analytical and problem-solving abilities, with a keen attention to detail.
- Proficient in using computer software and systems, including Microsoft Office Suite and database management tools.
- Ability to work independently and collaboratively as part of a team.
- Knowledge of healthcare information systems and electronic medical records is a plus.
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Estimated Hiring Range
At Vizient, we consider skills, experience, and organizational needs in our compensation approach. Geographic factors may adjust the range estimate and hires typically fall below the top range. Compensation decisions are tailored to individual circumstances. The current salary range for this role is $61,800.00 to $114,800.00.
This position is also incentive eligible.
Vizient has a comprehensive benefits plan! Please view our benefits here:
http://www.vizientinc.com/about-us/careers
Equal Opportunity Employer: Females/Minorities/Veterans/Individuals with Disabilities
The Company is committed to equal employment opportunity to all employees and applicants without regard to race, religion, color, gender identity, ethnicity, age, national origin, sexual orientation, disability status, veteran status or any other category protected by applicable law.