Position: Regulatory Affairs Specialist Location: Sparks, MD Duration: 3+ Months Contract Total Hours/week: 40.00 1st shift The Individual Will Work With Global Colleagues To Support Korea, China, And/Or Other Countries As They Fulfill Requirements To Register Products Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval. Responsibilities 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 to ensure that the appropriate regulatory requirements for the submission are met Interacts with regulatory body 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 #J-18808-Ljbffr