Regulatory Affairs Coordinator II

Acute Care TechnologyAt 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 Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You'll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL!

Job Summary

This role is part of ZOLL's Post Market Surveillance and Regulatory reporting program. Our Regulatory program is designed to meet the FDA's Quality System Regulation (QSR/Good Manufacturing Practices (GMP). This person will be instrumental in meeting Post Market Surveillance obligations surrounding submissions involving ZOLL devices domestically. There will be interdepartmental interactions involving Quality Assurance, Compliance, Technical Support, Service, and Regulatory Affairs surrounding Post Market Surveillance activity. There will be opportunities to showcase talents to continuously improve, develop, and foster growth.

Essential Functions

• Maintain ZOLL’s Post Market Surveillance documentation per ZOLL procedures and Regulatory requirements to stand on its own in the event of an audit.
• Identification of complaints and determination of reportability to various regulatory authorities.
• Updates to complaint files based on receipt of additional information as applicable.
• Completion and submission of documentation for reportable events to Competent Authorities within required timelines, including but not limited to FDA-3500A MedWatch Reports.
• Coordinate and maintain closure of complaint records in our Post Market Surveillance system.Provide support for Post Market Surveillance activities and training PMS Coordinators as needed.
• Support the review and evaluation of customer communications for complaint reporting obligations.
• Communicate and correspond with customers and team members effectively.
• Support departmental process improvements as they present.

Required/Preferred Education and Experience

• High School required
• Associate’s or Bachelor’s degree preferred
• 3 years experience Healthcare or Medical Device Industry preferred

Knowledge, Skills and Abilities

• Has knowledge of FDA 21 CFR Part 803, 3 years or greater of experience in an FDA-regulated environment preferred.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
• Ability to work in collaborative and independent work situations and environments with minimal supervision.
• Proficiency in Microsoft Tools, including but not limited to Outlook, Teams, Excel, Access, Word
• A strong attention to detail leading to outstanding quality of work.
• Ability to manage time efficiently and effectively.
• Possesses a positive attitude.
• Analytical and forward thinker.
• Ability to take constructive feedback for continued improvement.
• Quality or Regulatory experience in Medical Devices Experience preferred.

Physical Demands

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.

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

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's 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.

The hourly pay rate for this position is:

$21.20 to $31.70

Factors which may affect this rate include shift, geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.