Alyssa Skar Horst
About Alyssa Skar Horst
Alyssa Skar Horst is a Senior Regulatory Affairs Associate at Surmodics, Inc., specializing in EU and US regulations since 2022. She has extensive experience in regulatory affairs, quality audits, and technical documentation for medical devices.
Work at SurModics
Alyssa Skar Horst has been employed at SurModics, Inc. as a Senior Regulatory Affairs Associate (EU/US) since 2022. In this role, she is responsible for ensuring compliance with regulatory requirements for medical devices in both the European and United States markets. Her work includes writing and reviewing technical documentation for EU MDR Class IIa devices, which encompasses technical files and General Safety and Performance Requirements (GSPR) checklists. She also provides training on post-market device malfunction and deficiency reporting to notified bodies.
Education and Expertise
Alyssa Skar Horst holds a Master's degree in Biology/Biological Sciences from the University of Minnesota. She also earned a Bachelor of Arts in Biology/Biological Sciences from the University of Chicago. Her educational background provides a strong foundation for her expertise in regulatory affairs, particularly in the medical device sector. She has extensive experience in creating and implementing global work instructions for quality audits under ISO 13485 and ISO 9001 standards.
Background
Alyssa Skar Horst has a diverse professional background in regulatory affairs, having worked for several notable organizations. Prior to her current position at SurModics, she served as a Regulatory Affairs Specialist at Key Surgical from 2020 to 2021 and at Bracco Medical Technologies from 2021 to 2022. She also held roles at Medtronic, including Regulatory Affairs Specialist and Clinical Research Specialist, from 2018 to 2020. Her experience spans various aspects of regulatory compliance and clinical safety.
Achievements
Throughout her career, Alyssa Skar Horst has participated in significant projects related to regulatory compliance. She was involved in the front room experience for the Medical Device Regulation (MDR) upgrade and the ISO 13485 recertification process. Additionally, she has contributed to microbiology audits and has experience in writing and reviewing technical documentation for medical devices, ensuring adherence to regulatory standards.