We are seeking a leader for our quality and regulatory functions reporting directly to the CEO. In this role you will lead the quality strategies for new product development, advise the business and Board of Directors on regulatory and quality activities, develop, maintain and improve the company’s quality and regulatory systems, and ensure regulatory requirements are met so company products may be legally marketed.
We prefer candidates with a bachelor’s degree in a scientific discipline and a minimum of 6 years of technical experience in a quality or regulatory capacity supporting the full life cycle of class I and class II medical device products. Extensive knowledge of FDA regulatory and quality system requirements for medical device development, manufacturing and sales and previous management experience is required.
To be successful in this role you must be able to manage all aspects of the quality control, quality assurance and documentation control systems for the company, analyze product quality and develop plans and programs to support continuous quality improvement, maintain compliance of the company’s quality management system to new and revised regulations, and provide guidance to product development teams to ensure all regulatory and quality requirements are met through the development process.
We are interested in every qualified candidate who is eligible to work for any employer in the United States. However, we are unable to sponsor visas both currently and in the future.