Heather Marxhausen
About Heather Marxhausen
Heather Marxhausen is a Senior Regulatory Affairs Specialist at Boston Scientific with extensive experience in regulatory compliance and product performance analysis.
Title and Current Positions
Heather Marxhausen holds the position of Senior Regulatory Affairs Specialist at Boston Scientific. She is also serving as Principal Regulatory Compliance Specialist and Senior Regulatory Compliance Specialist in the same organization. Her multifaceted roles emphasize her comprehensive expertise and dedication in the field of regulatory affairs and compliance.
Employment History
Heather Marxhausen has had an extensive career history, with key roles at notable organizations. She worked at Boston Scientific as a Senior Product Performance Analyst from 2006 to 2010. Prior to that, she was a Product Marketing Specialist III at R&D Systems from 2003 to 2005, and also held a role in Research, Product Development, and Support at R&D Systems from 1999 to 2006. Early in her career, she worked as a Microbiology Associate at Mentor Corporation in 1999.
Education and Academic Background
Heather Marxhausen pursued her higher education at the University of Wisconsin-Madison, obtaining a B.S. in Bacteriology (Microbiology) from 1994 to 1998. Prior to her university education, she studied at Robbinsdale Armstrong from 1990 to 1994.
Regulatory Affairs Expertise
Heather Marxhausen has considerable expertise in coordinating submission activities for various device regulatory approvals, including US premarket approvals and international design dossiers. She acts as an internal consultant on regulatory issues, such as recalls, advertising, and promotional activities. Additionally, she excels in developing and delivering presentations to global regulatory agencies on submission strategies and compliance issues.
Leadership and Mentorship
Heather Marxhausen actively participates in training and mentoring within the regulatory affairs department. She leads and engages in department process improvements and systems development initiatives, while also collaborating with international regulatory business units, providing direct support with their submission-related activities.