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Complaint Specialist Consultant

Remote:

Full Remote

Contract:

Freelance

Experience:

Mid-level (2-5 years)

Work from:

United States

Offer summary

Qualifications:

Minimum of 2 years in Medical Device Complaint Handling, Medical device engineering experience, Knowledge of device complaint handling process including Adverse Event Reporting, Excellent written and verbal communication skills, Experience with Trackwise and Argus is a plus.

Key responsabilities:

Conduct post-market surveillance activities including complaint handling
Ensure compliance with department requirements and evaluate complaint files
Run containment reports and coordinate resolution activities
Communicate project risks and issues to the project lead
Complete assigned work activities on schedule and according to standards

RQM+ SME https://www.rqmplus.com/

501 - 1000 Employees

See more RQM+ offers

Job description

Your missions

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

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

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

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