Post Market Surveillance Coordinator II

ZOLL MEDICAL CORPORATION • Chelmsford, MA • 1d ago

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 SummaryThis 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 DemandsThe 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.

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