Post Market Surveillance Coordinator II

Acute Care Technology 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 Acute Care Technology division of ZOLL develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. 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 FDA's Quality System Regulation (QSR/Good Manufacturing Practices (GMP) MDD, EU MDR, MDSAP and the globally harmonized standard ISO 13485. This person will be instrumental in meeting Post Market Surveillance obligations surrounding submissions involving ZOLL devices. 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 in an effort to continuously improve, develop, and foster growth. Essential Functions Maintain ZOLL’s Post Market Surveillance documentation in accordance with ZOLL procedures and Regulatory requirements to stand on its own in the event of an audit. Complete and submit documentation for reportable events to Competent Authorities within required timelines, including but not limited to FDA-3500A MedWatch Reports, Manufacturing Incident Reports for EMEA Vigilance (both MDD and EU MDR), MDPR for Health Canada, etc. Coordinate and maintain closure of complaint records in our Post Market Surveillance system. Maintain the storage and retrieval of active and inactive complaint records. Provide support for Post Market Surveillance activities. Support the review and evaluation of customer communications for complaint reporting obligations. Communicate and correspond with customers. Required/Preferred Education and Experience High School required 1-3 years Healthcare or Medical Device Industry preferred Regulatory certification exposure to Post Market Surveillance Preferred Knowledge, Skills and Abilities Has Knowledge of FDA QSR, 803, MDD, MDR, ISO13458 and MDSAP is preferred. 2-5 years’ experience in an FDA and ISO regulated environment preferred. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Ability to work in collaborative and independent work situations and environments with minimal supervision. Attention to detail/Quality work. Ability to manage Time effectively. Positive attitude/Forward thinker. Analytical/ability to take initiative to correct problems. Quality or Regulatory experience in Medical Device 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' 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. 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 #LI-LV1 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.