Customer Service · Full-time · CO, United States
RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. RapidAI is empowering physicians to make faster decisions for better patient outcomes, leading the next evolution of clinical decision-making and patient workflow. Based on intelligence gained from over 10 million scans in more than 2,000 hospitals in over 60 countries, the Rapid® platform transforms care coordination, offering care teams a level of patient visibility never before possible. RapidAI – where AI meets patient care.
The Vice President, RAQA is a key leadership role reporting to the SVP Regulatory, Quality and Compliance, responsible for the management of Quality and Regulatory activities in support of the iSchemaView's growth objectives. In addition to their externally facing activities, they will play an important role collaborating cross-functionally with Product Development, Marketing, Legal and outside partners. The head of RA/QA will be a key leader in enhancing and developing the organization's RA/QA capabilities and qualifications to enable strategic initiatives once established.
What you will do:
Work with the SVP Regulatory Compliance, Development, implementation, maintenance and overall success of the company’s regulatory affairs and quality assurance strategy & programs; including
Establishing quality standards/metrics/objectives
Developing methods to embed quality into the product development process
Establishing supplier relationships and quality standards
Developing and implementing innovative programs to focus employees on improving product quality.
Implement process improvements required to ensure GxP compliance in early clinical development environment with strategic view to grow Quality function as the products advance to late-stage development and commercialization.
Building and managing relationships with FDA and global regulatory agencies and standards groups. Defining and implementing regulatory strategies and submissions in support of new and existing products as relevant.
Develop and maintain current regulatory knowledge and staying abreast of regulatory procedures and changes, interpreting regulations, providing regulatory insight, advice and support to other functions.
Coordinates internal and external quality audits and preparation of audit reports, corrective action plans and follow up updates.
Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective. Oversee global regulatory strategy and submissions in compliance with all applicable global regulatory requirements and in alignment with corporate goals.
Serve as the company representative for the FDA and other relevant external stakeholders. Ensure supplier quality objectives are met, provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the product pipelines.
Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of Quality. Implement, monitor, and promote best practices of Quality Management Systems to ensure compliance with relevant FDA, EU, and global regulations/directives/requirements
Identify, resolve, or escalate any and all product, process or customer Quality-related issues that pose risk with respect to the patient, customers or compliance.
Develop and manage department and study-specific budgets.
Initial focus will be on Quality Assurance with a transition to Regulatory Affairs.
Quality Management System (QMS) Leadership:- Monitor, implement changes, and maintain the organization's QMS to meet quality objectives and requirements worldwide.
Regulatory Compliance:- Stay current with relevant industry regulations and standards.
Quality Assurance Strategy:- Stay current with relevant industry regulations and standards.
Team Management:- Recruit, train, and mentor a high-performing team of quality professionals.
Quality Control:- Implement effective quality control processes and methodologies to monitor product or service quality.
Process Improvement:- Continuously assess and improve quality-related processes and procedures.
What you bring:
What we offer you: