Complaints Specialist Consultant

• 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

• 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.

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