Senior Director, Quality Assurance & Regulatory Affairs

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Job description

High growth, pre-IPO company in stealth mode

Join a rapidly growing company that is developing ground-breaking genomics technologies that will push the boundaries in the clinical, life sciences research and therapeutic fields. We are well-funded by global top-tier investors, including venture capital firms and growth equity investors. Our team brings together unique and diverse expertise across multiple disciplines, from healthcare and life sciences, to engineering, to technology and software and beyond. We are a collaborative group of more than 200 employees, including successful entrepreneurs, hardware and software engineers, genomics and biotechnology experts, molecular and computational biologists, software and algorithm experts, and operations and commercial leaders. Play an important role in the development and commercialization of technology and products that will accelerate our understanding of life, biology and disease and transform large industries.

We are looking for a highly motivated Senior Director, Quality Assurance & Regulatory Affairs to join our team!

The Senior Director, Quality Assurance & Regulatory Affairs will have oversight of all quality and regulatory activities for the company, including partnerships. You will be responsible for providing guidance for the design, development and manufacturing strategies for the genomics system and consumables and must have a demonstrated working knowledge of quality systems and compliance to support systems, software, service and consumables.

You will have a successful track record of managing and leading medical device quality and regulatory from product development through ongoing commercial manufacturing and customer support and be capable of applying them in a rapid growth environment. You are an innovative leader who blends strategy, operations, technology, and analytics to produce outstanding business results.

How You'll Contribute

• Partner with cross-functional teams in R&D, marketing, manufacturing operations and software to build overall quality and regulatory strategy and plans.
• Develop budget and resources plan for a quality/regulatory organization and system that provides flexibility but assures compliance for a competitive advantage through policies, standards and audit systems
• Prepare the company for regulatory submissions globally and maintain regulatory status through the lifecycle of the portfolio
• Provide leadership and guidance to the organization regarding quality, training and inspection readiness
• Work with senior leaders to establish a culture of quality in all activities of the business
• Direct or provide quality engineering guidance and support for product development planning and execution as needed
• Oversee the QA auditing program which includes assessing outside suppliers, contractors, and service providers by conducting internal and external quality audits and managing regulatory inspections
• Review and evaluate complaint/device malfunction records and investigation process
• Oversee document control activities (creating/routing/approving/completing) through the installation of industry-standard DMS
• Oversee company-wide quality and regulatory training
• Drive efforts to obtain regulatory clearances and ISO 13485 certification
• Conduct Quality Management Reviews with senior leadership

Qualifications, Skills, Knowledge & Abilities

• Degree (BS or MS) in a relevant Engineering, Biomedical Engineering, Biological Sciences
• 10 + years of experience in leading quality and regulatory activities; experience in a small/start-up company preferred
• Extensive experience with FDA inspections
• Deep knowledge of requirements for ISO 13485 certification
• Expertise in US FDA, EU and GMP regulations for medical devices
• Comprehensive experience in developing and executing global regulatory submissions
• Outstanding written and verbal communication skills with the ability to effectively influence internally and externally
• Excellent presentation skills with the ability to effectively communicate complex concepts to audiences of various backgrounds and knowledge levels