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Complaint Handling Regulatory Affairs Specialist

Complaint Handling Regulatory Affairs Specialist

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Quality, Regulatory Affairs, and Service

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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.


  • 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


  • 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:


  • 4-year degree or equivalent work experience
  • 8+ yrs. related experience preferred


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.