Complaint Specialist - Consultant

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RQM+

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RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts.

Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device

501 - 1000

Description

• 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.

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.)