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ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.
We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!
A stakeholder in ZOLL's Quality Assurance complaint handling process in accordance with the FDA’s Quality System Regulation (QSR)/ Good Manufacturing Practices (GMP) and globally harmonized standard ISO 13485. Reviews and assesses complaint information received from Technical Support. Based on information received, determines if events meet appropriate regulatory requirements for adverse event reporting. Generate appropriate regulatory reports based on assessment, communicate with other Sub-Office departments globally and respond to regulatory authority requests. This involves written documentation, computer input and interactions with internal and external customers. This position performs evaluations, preparations for audits, review and submission of regulatory documents and some oversight of the regulatory affairs program. In addition to creating and maintaining UDI related information in multiple systems. Providing UDI GTIN data to External and Internal Customers. Position will require reconciliation and auditing of the UDI related information and assisting in future UDI projects.
Essential Functions:
Maintaining ZOLL's complaint handling system in compliance within applicable regulations and procedures
Support quality improvement efforts.
Complies with U.S. Food and Drug Administration (FDA) regulations and other international regulatory requirements, company policies, operating procedures, processes, and task assignments
Interfaces directly with the FDA and other regulatory agencies
Keep up to date on regulatory changes and train company staff as needed on new policies and procedures
Maintain Regulatory Affairs databases, input data and control access as needed
Maintain regular status reports of regulatory activities
Review and assess product complaints for adequate information to determine if event meets Regulatory reporting requirements
Generate appropriate regulatory reports based on assessment
Communicate with other Sub-Offices globally as necessary for reporting
Coordinates information and generate responses to inquiries on Adverse Event reports from various global regulatory authorities
Assist in project management in collaboration with core team members
Track and communicate project status to all stakeholders by preparing status reports and participating in update meetings
Generate sound rationales for non-reportable events based on regulatory knowledge and/or clinical experience.
Maintains positive and cooperative communications and collaboration with all levels of employees and customers
Acts as a mentor to employees
Create and assign UDI GTINs to part numbers in the GS1 database
Work with multiple departments to collect UDI attribute data
Maintain accuracy of the FDA GUDID database
Provide UDI GTIN information to sales and marketing for bids and proposals
Manage ECOs in AGILE related to the creation of GTINs
Review ECOs in AGILE to ensure proper GTIN has been assigned to parts
Audit UDI data and maintain accuracy of the FDA GUDID database as well as AGILE and Oracle
Participate in setting up UDI for the EU and other countries
Skill Requirements:
Has knowledge of commonly used concepts, practices, quality tools, and procedures related to an electronic medical device environment
Skilled in a MS Windows environment. Competent with MS Office, including Excel, Access, PowerPoint, Visio and Word. Also operating with Oracle and Agile preferably.
Knowledge of FDA QSR, 803, and MDD is required. 2-5 years’ experience in an FDA and ISO regulated to complaint handling environment preferred
Ability to provide leadership, communicate and work effectively within a multi disciplined organization
Experience using mechanical and electronic test equipment would be beneficial
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Utilize appropriate complaint software systems for processing complaints
Must maintain company quality and quantity standards
Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
Excellent organizational skills with ability to work within defined deadlines
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Action-orientated: Ability to take initiative to correct problems or make changes for improvement without waiting for direction.
Proven ability to work successfully with other departments
Proven Customer interface skills
Prior UDI experience a plus
Required Education and Experience:
8 yrs. related experience preferred
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Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.
ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990
Full Time
Durable Manufacturing
$101k-131k (estimate)
04/12/2023
07/18/2024
zoll-lifevest.com
PITTSBURGH, PA
500 - 1,000
Private
MARSHAL LINDER
$50M - $200M
Durable Manufacturing