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 Regulatory Compliance Quality Manager is responsible for driving compliance with regulatory requirements through auditing, gap assessment, remediation and including management and support of Corrective/Preventive actions, Recalls, Warning letters, 483s, field corrective actions, and complaints. You will also ensure that the manufacturing process meets the external standards set by regulatory bodies such as the FDA, alongside the internal standards set by the client.

Responsibilities:

• Draft/issue Field Safety Notices (FSN) or Field Safety Corrective Action (FCSA) notices
• Reviewing complaints, identifying trends, and review of complaints regarding adverse event reporting to regulators.
• Directs the management of all business-impacting changes across the sites.
• Recognized as principal Quality contact and advocate to customers in assigned Product Category and represents Quality in Product Category customer business reviews, executive partnership meetings and customer escalation events, establishing and maintaining customer communications and credibility as the client champion.
• Plans, executes, and manages Quality related project activities across the Product Category sites with the site Quality managers.
• Provide leadership, project management, and identify resources needed to prepare for execution of remediation activities including systematic identification, risk-based prioritization and corrective action.
• Analyzes internal site assessment and audit trends to develop best practice processes.
• Drives consistent use of QA/RA KPIs across responsible plants to ensure measured performance improvements based on root cause analysis and defining/ deploying appropriate preventive and corrective actions.
• Establish timeline and develop/implement response to FDA 483s and warning letters making sure to adhere to the 15-day deadline for an initial response.
• Leads consolidation and communication of monthly report outs on key customer interactions, including complaint/post market status, Quality agreements, regulatory request status and product submission/certification status.

Requirements:

• Bachelor’s in Science, Engineering or a technical discipline. Master’s degree preferred.
• 12+ years of experience in Quality Assurance/ Regulatory Compliance in a medical device development and manufacturing environment.
• Minimum of 10 years of management experience in a medical device development and manufacturing environment with multi-site responsibility
• Experience in a regulated Medical Device environment in an engineering function dealing with processes and equipment in a cGMP/FDA/ISO manufacturing environment.
• Ability to partner effectively with internal and external partners in a proactive, positive and constructive manner.
• Ability to manage multiple projects and timelines, and accommodate multiple priorities in a fast paced and changing environment.
• Ability to systematically identify and resolve complex problems with an analytical data driven approach and creative thinking.
• Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm.
• Strong collaboration, communication and leadership skills to effectively and clearly coordinate across Product Category sites with the site QM.
• Experience and expertise applying change management principles and practices to drive successful enterprise transformation.
• Demonstrated influencing skills with all levels of key stakeholders during times of transformation and other situations.
• Experience with product development, design verification, validation, risk management.
•  Requires willingness to work 100% on-site.
• Self-motivated individual with a lead by example approach that endorses the company’s values and culture.
• Adheres to client values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• Demonstrated ability to establish, communicate, and implement long-term strategic and operational goals.
• Experience with advanced statistical methods: SPC, DOE, ANOVA and others. ASQ of equivalent Certified Quality Engineer, Certified Six Sigma Black Belt or Certified Quality Manager strongly preferred.
• Effectively able to manage large workflow and multiple projects at one time.
• Strong analytical, diagnostic, consulting and problem-solving skills and ability to tailor solutions to meet the needs of customers.
• Strong oral and written communication skills, including presentation skills and executive presence.
• 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.