Regulatory Affairs Specialist

Regulatory Affairs Specialist Responsibilities Regulatory Affairs is responsible for planning, coordinating and implementing regulatory submissions for products that require government approval. Demonstrates working knowledge of healthcare-related regulations. Demonstrates in-depth knowledge of preparing a submission. Demonstrates in-depth knowledge of industry and competitive products; applies relevant regulations and statutes to further product submissions of basic to medium complexity; contributes to the strategic direction of regulatory pathway development; refines and conforms the preliminary data used in the submission process. Translates technical data and descriptions into reviewer‑friendly content; helps ensure that the appropriate regulatory requirements for the submission are met; interacts with regulatory bodies to help further product approvals or clearance. Has in‑depth experience, knowledge, and skills in own job family; applies knowledge and skills to a wide range of standard and non‑standard situations; works independently with minimal guidance; usually determines own work priorities; acts as a resource for colleagues with less experience. Seniority Level Associate Employment Type Contract Job Function Legal Industries Staffing and Recruiting #J-18808-Ljbffr Indotronix Avani Group