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Complaints Manager

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Katalyst Healthcares & Life Sciences

2024-11-05 09:42:07

Job location Miami, Florida, United States

Job type: fulltime

Job industry: Other

Job description

Responsibilities:

Our medical device client in Miami, FL is looking for a Complaints manager to handle the entirety of the complaints system for Class II medical device.

They will be the main complaints person for the post-market quality team in charge of all handling and reporting.

Must have experience owning the complaints system, as well as experience with writing HHE's and MDRs.

The only notified body for reporting is FDA.

Requirements:

Relatively low volume, with 60 complaints/month and on 1-2 reportable events.

Additional experience with CAPAs is a big plus, but the focus of the role is complaints.

Minimum of 5+ years' experience, ideally working in both large and small companies.

Complaints are handled electronically using JIRA (plus).

Inform a friend!

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