Regulatory Affairs Specialist - On-site
$74,400–$111,600 year
On-site · Lafayette, Colorado, United States
Job Summary
Regulatory Affairs Specialist responsible for planning and delivering regulatory submissions (eCTD) and related documentation, cross-functional collaboration with R&D/Quality/Clinical/Marketing, training colleagues on regulatory systems and processes, and contributing to the continuous improvement of regulatory workflows. This on-site role supports market access and ongoing compliance for Cranial & Spinal Technologies within Medtronic CST, with responsibilities including preparing, publishing, and tracking regulatory submissions (initial marketing applications, supplements, annual reports, adverse event reports), maintaining regulatory-management systems, and providing leadership updates to senior management.
Required Qualifications
- Baccalaureate degree
- Minimum of 2 years of relevant experience in a regulated industry
- Experience with regulatory submissions (e.g., eCTD, marketing applications, annual reports, amendments, or adverse event reporting)
- Strong cross-functional collaboration skills and experience working with diverse stakeholder groups
- Strong attention to detail and ability to manage multiple projects and deadlines
- Effective written and verbal communication skills
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