Complaint Consultant (100% Remote) Jobs

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. In addition to early- and mid-stage MedTech companies, we currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

With over 500 team members globally, providing world-class consulting services in a remote capacity is nothing new for RQM+. We are dedicated to the highest levels of client service and employee satisfaction delivered with empathy, integrity, individual pride and company spirit.

The complaint consultant contributes to the delivery of regulatory and quality solutions to enable client success. The complaint analyst prepares work products and executes the defined consulting scope of work, with assistance of more experienced consultants as needed.

Responsibilities:

• Determine root cause of the late MDR and assign a defined action required for the cause
• Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
• Resourcing Service Detail Quality system improvements and remediation
• Conducts post-market surveillance activities including complaint/MDR handling, design history file remediation, and other remediation activities under supervision
• Will need to be able to evaluate complaint files that have been identified as being filed late with the reporting agency for an Adverse Event
• Report findings in Late MDR Review and MRB meetings to discuss findings
• Will ensure complaint containment reports are run as required procedures, and coordinate activities to resolve issues that appear on the reports
• Ensure report are run at the prescribed time frame and assign activities related to the reports for resolution
• Work with OEMs to perform appropriate laboratory testing for applicable complaints
• Review intake source systems, complaint handling databases, and other systems to determine chain of events in the complaint process
• When necessary, perform remediation activities on complaint files to bring them up to standard
• Perform appropriate evaluation steps to ensure all available information is present so that COE team can determine reportability
• Coordinate the report assignments to ensure activities are completed in a timely manner and escalate issues to the appropriate department for resolution if required
• Communicates project risk and issues to the project lead in a timely fashion
• Ensure complaint meets department requirements prior to transferring complaint to the legal manufacturer for investigation

Requirements:

• Experience working Trackwise and Argus is a plus
• Minimum of 5 years of experience in Medical Device Complaint Handling
• Experience working on Complaint remediation projects is a plus
• Experience completing device complaint investigations and reportability determinations
• Knowledge and understanding of end to end device complaint handling process including Adverse Event Reporting to US FDA (MDR) and OUS Regulators
• Able to clearly explain and present technical information within and outside of the organization (i.e. technical resource to 3rd Party vendors, medical personnel, marketing, service publications, training, R&D, etc.)
• Experience with Combination products is a plus
• Understands and complies with all current cGMP and QSR requirements as defined by management our/or outlined in standard operating procedures as well as recording necessary documentation to comply with various regulatory agencies
• Ability to manage multiple cases in parallel to ensure timely completion of activities
• Excellent written and verbal communication

Being an industry leader in client support is just the beginning for RQM+.  Providing a rewarding place to work is rooted deep in the core values of RQM+.  From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment.  At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today!

We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us.

We require willingness to work a flexible schedule and travel at least 25% of the time