Senior Regulatory Specialist - Argon Medical Devices : Job Details

Join to apply for the Senior Regulatory Specialist role at Argon Medical Devices, Inc.Join to apply for the Senior Regulatory Specialist role at Argon Medical Devices, Inc.Position OverviewThis position authors regulatory submissions and technical documentation to support OUS markets as well as organizes regulatory information and tracks/controls submissions. Reviews and provides recommendations on labeling for compliance with regulatory filings. Performs reviews of product changes for impact on regulatory filings worldwide.Position OverviewThis position authors regulatory submissions and technical documentation to support OUS markets as well as organizes regulatory information and tracks/controls submissions. Reviews and provides recommendations on labeling for compliance with regulatory filings. Performs reviews of product changes for impact on regulatory filings worldwide.What You Will DoProvide regulatory guidance to colleagues to ensure subsequent documentation will meet the needs of the regulatory submissions.Prepare European technical documentation and other OUS license applications.Lead project for gap remediation with a cross functional team.Prepares and submits filings.Maintain regulatory files/database and chronologies in good order.Establish and maintain system for tracking changes in documents submitted to agencies or partners.Review labeling and labels for compliance with regulatory requirements.Review changes to existing products and SOPs to define the requirements for regulatory submissions.Skills For SuccessBachelor's degree in science, math or engineering discipline required.5+ years relevant experience in FDA regulated industry.Experience and knowledge within medical device industry (disposable devices preferred).Knowledge of international regulatory requirements applicable to medical devices.Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.Strong attention to detail and ability to manage multiple projects simultaneously.Seniority level Seniority level Not ApplicableEmployment type Employment type Full-timeJob function Job function LegalIndustries Medical Equipment ManufacturingReferrals increase your chances of interviewing at Argon Medical Devices, Inc. by 2xGet notified about new Senior Regulatory Specialist jobs in Plano, TX .Frisco, TX $100,000.00-$130,000.00 4 days agoCarrollton, TX $100,000.00-$125,000.00 4 days agoSenior Regulatory Reporting Specialist - Hybrid Principal Consultant: Commercial and Regulatory Research Global KYC Policy, Regulatory & Execution, Vice President Irving, TX $126,000.00-$164,000.00 2 months agoMorgan Stanley E*TRADE Regulatory Attorney Senior Counsel, Litigation, Regulatory Enforcement & Employment Food Safety and Regulatory Affairs Manager Dallas, TX $97,199.00-$162,049.00 4 days agoGT Risk and Regulatory Portfolio Executive - Business Control Executive Senior Director of Regulatory Operations, 2 Hour Learning (Remote) - $400,000/year USD Manager, Hospital Regulatory & Accreditation (Remote based in US) Tech Risk and Controls Lead - Regulatory & Industry Risk Assessments Financial and Regulatory Accountant - Denton, TX Director, Regulatory Risk - Financial Services Risk, Liquidity Risk (Regulatory), Vice President, Dallas Dallas, TX $144,200.00-$265,600.00 2 weeks agoAI & Data Manager - Life Sciences R&D Regulatory (Pharma) Dallas, TX $130,800.00-$241,000.00 4 days agoQuality – Specialist, Regulatory Reporting Plano, TX $60,000.00-$120,000.00 2 weeks agoRegulatory Reporting - Financial Specialist Dallas, TX $74,826.00-$93,532.00 3 weeks agoRegulatory Correspondence Spec I (Onsite) Global Banking & Markets Operations-Dallas-Associate-GBM Regulatory Controls Senior Compliance Specialist - Regulatory Change & Inventory Management Irving, TX $84,000.00-$149,400.00 18 hours agoWe're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.#J-18808-Ljbffr