Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Overall responsibility for leading the corporate product quality systems, including the setting of quality goals, managing and improving all aspects of the quality system and product quality to ensure corporate compliance with US FDA or other applicable competent authority regulations, policies, and guidelines
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop and oversee execution of company goals and objectives. Provide management and leadership to the Regulatory Affairs, Quality Assurance and Product Quality functions in the development and implementation of compliant and efficient regulatory strategies and processes.
Coach and mentor the Quality and Regulatory team to ensure appropriate levels of accountability for decision making, enhance knowledge of regulatory and quality concepts, and clearly communicate cross functionally within the organization. Regularly discuss progress and issues with President/CEO.
Direct the regulatory compliance function to ensure regulatory requirements of the various QED markets are met, including regulatory submissions to government agencies.
Assist with internal audits; lead, third-party audits, audit responses and non-conformities.
Review complaints and potentially reportable events, manage recalls and related reporting.
Develop or revise controlled documents to ensure they are streamlined as much as possible, cost-effective QA tools, and procedures pertinent to RA/QA/PQ activities and functions, as well as other procedures if deemed necessary.
Assist in the development and implementation of RA/QA training-develop and review material, identify needs/gaps.
Oversee regulatory and quality assurance compliance for the QED Research Center.
Identify opportunities for cost-effective, time-efficient and compliant changes to the quality system throughout the company and collaborate with others for their implementation.
Act as the Management Representative for the quality system and chair quality system management review meetings.
QUALIFICATIONS: Education and Experience
BS or BA
Minimum 10 years of experience working in a regulated environment (medical device, biologics, or pharmaceutical).
Regulatory knowledge including global requirements for marketing approvals, complaint handling, adverse event reports, recalls, labeling and quality systems, quality concepts and principles.
Required Skills and Abilities
Knowledge of 21 CFR 820(QSR), ISO 13485, ISO 14971, EU MDR, Health Canada, JPAL, MDSAP
Ability to communicate effectively both verbally and in writing; and to inspire and influence others
Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors
Strong critical thinking and problem solving skills
Competency in applying scientific principles and logical thought processes in preparing regulatory and quality documentation
Management and leadership ability
Time management, planning and organizational capabilities
Experience with FDA inspections, and strategies for successful outcomes and responses
Preferred Skills and Abilities
Familiarity with product lifecycle management (PLM) software and Agile
Familiarity with IEC and IPC standards
Familiarity with clinical studies, IRBs
Independent certification in Regulatory Affairs, Quality Assurance/Audits or relevant specialized training
Internal Number: 092818
About Quality Electrodynamics (QED)
Quality Electrodynamics (QED), located in Mayfield Village, OH, is a global developer, manufacturer, and supplier of advanced medical equipment electronics. Current products include cutting-edge MRI radiofrequency (RF) antennas/coils for diagnostic imaging at the full range of magnetic field strengths. Most of these are FDA Class II noninvasive devices used for obtaining diagnostic images for various human anatomies.