THE RESPONSIBILITIES

This position is responsible for the day to day management of Quality and Regulatory Affairs activities. It is a remote telecommute position with 30+% travel. The role provides strategic regulatory support for all operations and operational support for the implementation of systems and procedures used to support quality and compliance standards, import/export, registrations, notifications, certifications, and maintenance throughout the whole specimen life-cycle.

The role will establish strong relationships within regional and local business partners on a cross-functional basis including Research & Development, Marketing, Legal, Consumer Affairs, and Supply Chain to ensure alignment and synchronization between Regulatory & Quality strategies and Business goals.

The Quality and Regulatory Affairs Manager will drive the strategic and operational performance of the Quality department. This position ensures the successful delivery of business strategy and operational goals to exceed customer expectations for product quality, customer service, engineering quality, cost and delivery, while facilitating continuous improvement and achieving commercial success. Applies Lean Manufacturing methods and applies statistical process control techniques to improve the statistical process capability. The Manager will develop, lead, and manage the quality team and ensure the efficient and effective day to day running of the department. 
The Quality Manager must be a change agent and possess hands-on management skills.

KEY DUTIES AND RESPONSIBILITIES

• Lead the development and execution of strategic plans to meet departmental and organizational goals while complying with regulatory and customer requirements. 
• Strong customer-facing communicator and negotiator. Timely, reliable responsiveness to complaints, questionnaires or other Quality Assurance concerns with other departments. Facilitate exchange of information in order to implement change and improvements regarding quality. 
• Leads Continuous Improvement initiatives and applies root-cause problem-solving techniques to improve product quality, to reduce costs and to minimize waste. Understands the production processes and the inter-relationships. 
• Provide leadership and guidance to assure corrective actions are resolved, adequate root cause analysis is completed and short/or long-term corrective actions are implemented. 
• Continually partner with Research & Development, Commercial partners, Engineers and customers to develop specifications to ensure that customer requirements and company specifications match. Resolve contradictions with customer's specifications and procedures. 
• Provide progress reports/Quality Key Performance Indicators (KPIs) to Senior Management. 
• Develop, implement, and maintain Quality Systems. 
• Responsible for publishing and approving documents. Maintaining and continuously improving quality system processes as required by international, regional and national regulatory authorities and standards, ISO 9001 and FDA QSR. 
• Functioning as the leader and management representative during audits, internal and external. 
• Lead day-to-day Regulatory Affairs and Quality operations by directly or indirectly managing internal individual contributors and/or managing third-party vendors to ensure timely project execution according to defined project strategies and timelines.
• Stay abreast of changes to business-relevant standards and regulations and develop plans to ensure products and processes are up-to-date on all pertinent requirements.
• Coordinate the compliance program for outsourced activities and suppliers
• Ensures compliance with administrative, legal and regulatory requirements.