Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistMy client is seeking a Senior Regulatory Affairs Specialist to help simplify diabetes management through insulin pump technology. The goal is to empower people to manage their diabetes with ease, without needing to be experts in tech or math.** Competitive hourly rate with potential for contract extension.Key *Provide regulatory guidance and feedback to project teamsDevelop regulatory strategies for new devices and post-market changesPrepare filings for new products and major changesIdentify and communicate risks in regulatory strategiesLead and negotiate regulatory meetings with government agencies (e.g., FDA, Notified Bodies)Lead the preparation of regulatory filings (PMAs, 510(k)s, EU Technical Documentation)Ensure compliance with US regulations, ISO 13485, MDD/MDR, CMDR, and othersAssist in training junior staffOther duties as neededEducation & *Bachelor's degree in Science, Engineering, or related field4+ years in Regulatory Affairs in medical devices or similar regulated industriesRequired *Strong communication skills (written & verbal)Experience with FDA, ISO, EU regulations for medical devicesFamiliarity with regulatory requirements for complaint handling, reporting, and CAPAProject management, organizational, and analytical skillsBenefits May VaryPreferred *Knowledge of medical device processes (e.g., reliability, software, biocompatibility)** Only local applicants with the legal right to work in the US will be considered.Interested? Contact Reese Owens on LinkedIn or at 202-967-3339. You can also email your resume to .

Created: 2025-02-19