ZOLL Cardiac Management Solutions · 1 week ago
Regulatory Affairs Coordinator II
United States
Full-time
Remote
Mid Level
$21.20/hr - $31.70/hr
3+ years expZOLL Cardiac Management Solutions is dedicated to improving patient outcomes through innovative medical technologies. The Regulatory Affairs Coordinator II will support ZOLL's Post Market Surveillance and Regulatory reporting program, ensuring compliance with FDA regulations and coordinating complaint records and documentation for reportable events.
Medical Device
Responsibilities
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
Qualification
Required
High School required
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
Preferred
Associate's or Bachelor's degree
3 years experience Healthcare or Medical Device Industry
Has knowledge of FDA 21 CFR Part 803, 3 years or greater of experience in an FDA-regulated environment
Quality or Regulatory experience in Medical Devices Experience
Company
ZOLL Cardiac Management Solutions
ZOLL Cardiac Management Solutions (CMS), a division of ZOLL Medical Corporation, offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes in cardiac patient care.
1001-5000 employees
H1B Sponsorship
ZOLL Cardiac Management Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageCompany data provided by crunchbase