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ZOLL Medical Corporation · 2 days ago

Regulatory Affairs Coordinator II

United States

Full-time

Remote

Mid Level

$21.20/hr - $31.70/hr

3+ years exp

ZOLL Medical Corporation is dedicated to improving patient outcomes through innovative medical technologies. The Regulatory Affairs Coordinator II will support the Post Market Surveillance and Regulatory reporting program, ensuring compliance with FDA regulations and maintaining documentation for ZOLL devices.

Health CareMedical DeviceSoftware

H1B Sponsor Likely

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

FDA 21 CFR Part 803Post Market SurveillanceHealthcare Industry ExperienceMedical Device Industry ExperienceMicrosoft Tools ProficiencyAnalytical ThinkingCommunication SkillsAttention to DetailTime ManagementPositive Attitude

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 preferred

3 years experience Healthcare or Medical Device Industry preferred

Has knowledge of FDA 21 CFR Part 803, 3 years or greater of experience in an FDA-regulated environment preferred

Quality or Regulatory experience in Medical Devices Experience preferred

Company

ZOLL Medical Corporation

Glassdoor3.3

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.

Founded in 2004

Pittsburgh, Pennsylvania, USA

1001-5000 employees

https://www.lifevest.zoll.com

H1B Sponsorship

ZOLL Medical Corporation 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

2025 (13)

2024 (6)

2023 (8)

2022 (8)

2021 (2)

2020 (6)