Jen Schultz
About Jen Schultz
Jen Schultz is a Senior Regulatory Affairs Specialist at Boston Scientific with extensive experience in quality assurance and regulatory roles in the biomedical industry.
Current Role at Boston Scientific
Jen Schultz is serving as the Senior Regulatory Affairs Specialist at Boston Scientific since 2019. She is based in Minnetonka, MN. In this role, she is responsible for ensuring compliance with regulatory requirements and developing strategies to streamline product approvals. She leverages her extensive background in quality assurance and regulatory affairs to contribute to the company’s objectives.
Previous Experience at Lifecore Biomedical
Jen Schultz has an extensive tenure at Lifecore Biomedical, working in different capacities from 2011 to 2019. Initially, she served as a Senior Quality Assurance Engineer for six years, focusing on compliance and quality system improvements. Later, she transitioned to the role of Senior Regulatory Affairs and Product Support Specialist, where she worked until 2019, ensuring that products met stringent regulatory standards.
Early Career and Positions Held
Jen Schultz's career began at Kemps as a Quality Assurance Technician from 2003 to 2004. Thereafter, she moved to PDL BioPharma, Inc. as a QC Chemistry Analyst II, holding the position for three years. She then joined Hawkins, Inc. as a Senior Quality Assurance Specialist and subsequently worked as a Quality Engineer at St. Jude Medical for six months. Each role contributed to her growing expertise in quality assurance and compliance.
Educational Background
Jen Schultz possesses a robust educational foundation, having studied Biology and Chemistry at Concordia College, where she earned her Bachelor’s Degree from 1999 to 2002. She further enhanced her professional credentials by achieving a Six Sigma Green Belt from the University of St. Thomas – Opus College of Business in 2015.
Certifications and Expertise
Jen Schultz is a certified Quality Auditor by ASQ, receiving her certification in April 2017. She has expertise in various statistical tools and problem-solving methodologies, including A3, Process Mapping, DMAIC, and Value Stream Mapping. She is proficient with software tools such as CATSWeb, Pilgrim EDMS, Fourth Shift ERP, Windchill PDMLink, JD Edwards, Labelview, Microsoft Office, Minitab, and Adobe, which aid in her regulatory and quality assurance roles.