Richard Lauhead
About Richard Lauhead
Richard Lauhead serves as the Senior Program Lead for Regulatory Affairs at Biosense Webster, where he develops regulatory strategies for medical devices and communicates with regulatory agencies. He has a background in bioengineering and has held various roles in academia and the medical device industry.
Work at BioSense
Richard Lauhead has been serving as the Senior Program Lead in Regulatory Affairs at BioSense Webster since 2016. In this role, he participates in new product development teams, reviewing and approving documentation for new products and modifications. He is responsible for developing regulatory strategies for class II and III medical devices, ensuring compliance with global commercialization standards. Richard communicates directly with the FDA and other regulatory agencies to prepare responses to submissions and support agency audits. His experience includes evaluating proposed changes to product design or manufacturing processes for their impact on worldwide approvals and internal policies.
Education and Expertise
Richard Lauhead holds a Master of Science in Bioengineering from the University of California, Riverside, which he completed from 2010 to 2011. He also earned a Bachelor of Science in Bioengineering from the same institution, graduating in 2010. His academic background provides a strong foundation for his work in regulatory affairs, particularly in the medical device sector. Richard's expertise encompasses regulatory strategy development, compliance with global standards, and technical documentation for medical devices.
Background
Before joining BioSense Webster, Richard Lauhead worked in various roles that contributed to his professional development. He was a Quality Engineer at BioSense Webster from 2011 to 2016, where he gained experience in quality assurance and regulatory compliance. Additionally, he served as a Toxicology Intern at Isis Pharmaceuticals from 2006 to 2007. His academic involvement includes positions as a Supplemental Instructor Leader and Research Assistant at the University of California, where he engaged in teaching and research activities.
Achievements
Throughout his career, Richard Lauhead has authored technical files and design dossiers for products distributed in the European Union. His contributions to regulatory affairs include developing strategies that ensure compliance with global standards for medical devices. His ability to communicate effectively with regulatory agencies, including the FDA, has been instrumental in preparing responses to submissions and supporting agency audits.