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VP, Medical Devices Quality and Regulatory Affairs Leader

1 month ago

Hopkins, Minnesota, United States Stratasys Full time

Stratasys is a world leader in 3D printing and additive manufacturing. We are seeking a highly experienced VP, Medical Devices Quality and Regulatory Affairs Leader to lead all aspects of quality assurance and regulatory compliance across the Global Enterprise.

This role requires a deep understanding of global regulatory frameworks, as well as experience in navigating complex quality systems within the 3D printing or advanced manufacturing sectors. The ideal candidate will have a proven track record of successfully leading quality and regulatory functions in a global environment.

The successful candidate will be responsible for developing and implementing a comprehensive quality strategy that aligns with the company's goals and objectives. They will also oversee the development, implementation, and maintenance of the company's Quality Management System (QMS) and ensure all processes, from product design to manufacturing, meet established quality standards.

The VP, Medical Devices Quality and Regulatory Affairs Leader will also be responsible for ensuring compliance with all relevant international, federal, and state regulations, including ISO, FDA, CE Marking, and other applicable standards. They will lead the preparation and submission of regulatory filings, product registrations, and other required documentation.

The ideal candidate will have 10+ years of experience in quality assurance and regulatory affairs, with a significant portion in medical device or advanced manufacturing industries. They will also have experience leading global quality teams and have a strong understanding of lean six sigma principles.

Stratasys is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.