Regulatory Affairs Consultant

Regulatory Affairs Consultant (Contract-to-Hire) We are seeking a Regulatory Affairs Consultant for a 6-month contract-to-hire opportunity supporting Class II medical devices, with a strong focus on SaMD. 6-month contract-to-hire 40 hours per week Hybrid: 2–3 days onsite near St.Paul, MN Responsibilities Lead and support preparation and filing of FDA 510(k) submissions Manage FDA communications related to submissions and regulatory strategy Support regulatory activities for Class II devices, including SaMD Qualifications 5–7 years of Regulatory Affairs experience Hands‑on experience with 510(k) filings Strong background in SaMD and Class II devices Proven experience interacting directly with the FDA This role is ideal for a hands‑on regulatory professional looking to transition into a long‑term position. #J-18808-Ljbffr