Regulatory Affairs Consultant

meet life sciencesSaint Paul, MNyesterday

Occupations

Regulatory Affairs Specialists Regulatory Affairs Managers Compliance Managers

Industries

Electromedical and Electrotherapeutic Apparatus Manufacturing Other Scientific and Technical Consulting Services Surgical and Medical Instrument Manufacturing

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.

Apply now

Level

SeniorL5

Location

Saint Paul, MN

Occupation

Regulatory Affairs Specialists

Industry

Electromedical and Electrotherapeutic Apparatus Manufacturing

Posted

yesterday

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