Senior Regulatory Affairs Specialist (Hybrid)

We are currently seeking a Senior Regulatory Affairs Specialist to join our Medical Division to be based Hybrid Monday through Wednesday in Redmond, Washington.What you will doAs part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market and ensure ongoing compliance.Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfersIdentify regulatory and market access requirements, including federal, state/provincial, reimbursement, and purchasing group considerationsDevelop and update regulatory strategiesin response to evolving regulations and product development needsEvaluate product classification and jurisdiction, and determine appropriate regulatory pathways and compliance requirements (local, national, international)Prepare and submit regulatory submissions(electronic and paper) in accordance with applicable guidelines and maintain communication with regulatory authorities throughout the review processProvide regulatory guidance throughout the product lifecycle, including development, planning, labeling, and claims, while maintaining current product registrationsAssess proposed pre-clinical, clinical, and manufacturing changesfor regulatory impact and recommend filing strategies or alternatives when submissions are not requiredBuild relationships and interface with cross-functional teams (Engineering, International RA, Manufacturing, Marketing, etc.) to ensure accurate, complete, and timely submission preparationWhat you needRequiredBachelor’s degree in an Engineering, Science, or equivalent fieldMinimum of 2 years of experience in an FDA or highly regulated industryMinimum of 1 year in a Regulatory Affairs rolePreferredRAC certification or Advanced Degree (Masters in Regulatory Affairs)Previous experience with Class II/III medical devicesExperience authoring regulatory submissions for product approvalExperience interacting with regulatory agencies$88,000.00- $142,300.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on dividual pay is based on skills, experience, and other relevant factors. #J-18808-Ljbffr

Created: 2025-10-08