Regulatory Affairs Specialist

Position Regulatory Affairs Specialist [Local & Remote eligible] Location Tempe, AZ Duration 12+ Months Contract Hours 40 hours/week, 1st Shift Client Medical Device Company Job Category Regulatory Affairs / Compliance Employment Type Contract on W2 (U.S. Citizens or Green Card holders only). No H1B visas. Eligibility Local and remote candidates may be considered. Must be detail oriented, flexible, and possess strong technical writing skills. Responsibilities Manage product remediation projects and process/system remediation initiatives. Prepare regulatory submissions required to legally market medical devices in the European Union under the MDR. Support global product registrations and related regulatory affairs activities as needed. Translate technical data and descriptions into reviewer‑friendly content. Interact with regulatory bodies to advance product approvals or clearances. Execute project activities that ensure product development adheres to all regulatory requirements and business objectives. Manage change, work independently with minimal guidance, and determine own work priorities. Collaborate with regulatory and cross‑functional team members, building strong working relationships and serving as a resource for colleagues with less experience. Qualifications Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering, or a medical‑related field. 4+ years employment in Regulatory Affairs, product registration, compliance, or quality systems (preferred). Demonstrable in‑depth knowledge of preparing submissions, applying relevant regulations and statutes, and translating technical data into reviewer‑friendly content. Ability to manage change, work independently, and prioritize tasks with minimal guidance. #J-18808-Ljbffr MillenniumSoft Inc