A Consultant with RQM+ is responsible for the delivery of service offerings. This role is responsible for the execution of the defined consulting scope of work. The Consultant contributes with the delivery of regulatory and quality solutions that are best practice, innovative, and enable client success through delivery of superior service under the direction of project leadership. The Consultant is focused on contributing to the delivery of regulatory services and to timely execute specific deliverables against timelines and budgets for projects.

The complaint analyst 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.  

This positions requires someone who is in the CET time zone

4- 6 week project

Responsibilities:

• Handle complaints from intake through closure, including analysis, investigational support, reportability determination, and MDR/Vigilance report preparation when required.
• Review product quality complaints and adverse events, evaluate investigation requirements and close with rationale or indicate additional activities.
• Review production, design, use, failure analysis for reported events and related investigations
• ·Make reportability determinations using a decision tree.
• Ensure complaints are processed in a timely manner to maintain compliance with company procedures.
• Ensure timely submission of complaints requiring an MDR to the FDA within 5 or 30 days as required per 21 CFR Part 803 and other applicable global regulatory agency requirements and ensure supplemental MDR is submitted within 30 days of the new or added information.
• Coordinate/investigate device complaints in accordance with 21 CFR Part 820.198 and company policy
• Understand and comply with processes defined for handling complaints with a serious safety issue.
• Senior complaint specialists:
• Lead or participate in the MDR decision committee
• Determine whether a device is reportable to the FDA or other regulatory body or agency
• Raise a CAPA if indicated
• Develop/improve decision trees

Requirements:

• Experience in Medical Device Complaint Handling
• 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.
• Understand and comply 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.
• Familiarity working with safety databases such as Argus and MAUDE are 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.)
• Self-motivated individual with a lead by example approach that endorses the company’s values and culture.
• Working understanding of the RQM+ business, organization roles and responsibilities, the internal quality system, and operating systems and how to effectively maneuver within each preferred.
• Regulatory knowledge and technical background.
• Strong analytical, diagnostic, consulting and problem-solving skills and ability to tailor solutions to meet the needs of customers.
• Strong desire for continuous learning
• Strong oral and written communication skills, including presentation skills and executive presence.
• Excellent interpersonal, communication and influencing skills and experience working with clients, employees, and the medical device industry.
• High performance orientation, a detail orientation, and strong organization skills.
• Advanced computer skills including data analysis and report writing required.
• Consulting services are focused on creating a culture of respect and continuous improvement with the aim of generating maximum value for customers and stakeholders by identifying value and eliminating waste in processes.
• Requires willingness to work a flexible schedule and travel at least 25% of the time.