Complaint Specialist Consultant

 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 and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

As a complaint consultant you will support the complaint investigation process and execution for product design and process related complaints for Post-Market Medical Device and Combination Products.

Responsibilities:

• Conducts post-market surveillance activities including complaint/MDR handling
• Will ensure complaint containment reports are run as required procedures, and coordinate activities to resolve issues that appear on the reports.
• Ensure complaint meets department requirements.
• Perform appropriate evaluation steps to ensure all available information is present so that team can determine reportability.
• When necessary, perform remediation activities on complaint files to bring them up to standard.
• 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.
• Review intake source systems, complaint handling databases, and other systems to determine chain of events in the complaint process.
• Coordinate the report assignments to ensure activities are completed in a timely manner and escalate issues to the appropriate department for resolution if required
• Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
• Communicates project risk and issues to the project lead in a timely fashion

Requirements:

• Minimum of 2 years of experience in Medical Device Complaint Handling
• Medical device engineering experience
• Knowledge and understanding of end-to-end device complaint handling process including Adverse Event Reporting to US FDA (MDR) and OUS Regulators
• Combination product experience
• Experience completing device complaint investigations and reportability determinations
• Excellent written and verbal communication
• Ability to manage multiple cases in parallel to ensure timely completion of activities
• 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
• Experience with Combination products is a plus
• Experience working Trackwise and Argus is a plus
• 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.)

Being an industry leader in regulatory and quality consulting is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.