Regulatory Affairs - Specialist 3

Regulatory Affairs Specialist - Onsite (Urgent Need) Location: Irvine, CA | Contract Duration: 9 months | Salary: $69,510.00 - $126,382.00 Overview Locals Only - Onsite in Irvine, CA (Hybrid) Responsibilities Planning, coordinating, and implementing regulatory submissions for products requiring government approval. Demonstrated working knowledge of healthcare-related regulations. In-depth knowledge of preparing a submission and understanding of industry and competitive products. Application of relevant regulations and statutes to further product submissions of basic to medium complexity. Contributing to the strategic direction of regulatory pathway development. Refining and conforming the preliminary data used in the submission process. Translating technical data and descriptions into reviewer-friendly content. Ensuring that the appropriate regulatory requirements for the submission are met. Interacting with regulatory bodies to help further product approvals or clearance. In-depth experience, knowledge, and skills in own job family. Applying knowledge and skills to a wide range of standard and non-standard situations. Working independently with minimal guidance and usually determining own work priorities. Acting as a resource for colleagues with less experience. Qualifications In-depth experience, knowledge, and skills in the regulatory affairs job family, including the ability to work independently and act as a mentor to less experienced colleagues. #J-18808-Ljbffr Sunrise Systems, Inc.