Senior Regulatory Affairs Associate

A bit about us:Based in Madison, WI, we are a a digital health solutions company advancing care and developing novel digital therapeutics. We are looking for a Senior Regulatory Affairs Associate to join our growing team!Why join us? Competitive Salary! Great Benefits Package! The Opportunity to Join an Amazing Team!Job Details BA/BS or MS degree in health or science related discipline Five to ten years of professional experience in submitting medical device products for regulatory approval Experience in regulatory strategies, product development, GMP, and regulatory submissions and registrations including but not limited to FDA and EU Extensive experience in medical device regulations include the US and EU regulatory requirements Experience with medical device standards and guidance's such as ISO 14971, ISO 14155, IEC 62304, EN 62366, etc., a plus Experience with clinical investigation, a plus Responsible for developing, writing and implementing regulatory strategy for assigned projects Provides advice and support to project teams for regulatory operations aspects of projects ensuring adherence and compliance. Actively drives interactions with regulatory bodies as assigned Provides regulatory support for EU Technical Files conforming to EU MDR