What are the responsibilities and job description for the Complaint Handling Consultant position at Redbock - an NES Fircroft company?
COMPLAINT HANDLING CONSULTANT (6-months, Possibility of Extension)
SUMMARY:
Contractor needed to support medical device complaint handling and reporting activities for a thriving industry leader.
DUTIES & RESPONSIBILITIES
* Intake, entry, investigating and overall handling of complaints, and relevant documentation and closure
* Filing/submitting of reports, as needed
* Team communications
* Other duties, as required
QUALIFICATIONS & REQUIREMENTS
* 8 years of experience in investigating, handling, documenting and preparing reports for medical device complaints, including complaints related to implantable medical devices (Full cycle, intake to closure)
* Good verbal and written communication skills, including ability to prepare well-crafted technical/clinical narratives
* Understanding of relevant ISO, FDA, MEDDEV/Vigilance, and Health Canada MDD compliance and reporting requirements relevant to Class II & III devices
* Strong computer proficiency, including Microsoft Office and Microsoft Teams
* FDA AND EU complaint reporting experience is strongly preferred
LOCATION:
Work can be performed remotely from home