Post Market Surveillance Coordinator II
ZOLL Medical Corporation
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 Resuscitation division of ZOLL Medical Corporation 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!
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.
- 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.
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.