Regulatory Affairs Complaint Investigator (Fda)

At ZOLL, we're passionate about improving patient outcomes and helping save lives.

We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.

ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.

Job Summary

This position is responsible for acquiring and compiling information related to complaint investigations for final RAE review and approval.

Essential Functions

• Provide administrative support during product recall notifications, advisory reports, and incident reports.
• Liaise with the distributor, service, and engineering departments in acquiring relevant information for complaint investigations.
• Compile complaint investigation information for final RAE review and approval.

Required/Preferred Education and Experience

• Experience with Microsoft Access Preferred
• Associate's Degree In Life Sciences or a Technical Discipline. Required

Knowledge, Skills and Abilities

• Strong typing skills.
• Strong knowledge of Microsoft Excel, Word, Outlook, and Adobe Acrobat software.
• Ability to operate photocopiers, scanners, and personal computers.
• Requires a high level of attention to detail and be able to multi-task.

Physical Demands

• While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working Conditions

• The noise level in the work environment is usually quiet.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.