Regulatory Specialist

This range is provided by ACE Partners . Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$70,000.00/yr - $92,000.00/yrDirect message the job poster from ACE PartnersEmpowering the Next Generation of Vascular MedTech with Top TalentJob Title: Regulatory SpecialistOverview:This role is responsible for ensuring regulatory compliance by managing recalls, medical device reports (MDRs/MPRs), and critical complaints. The Specialist will lead regulatory submissions, liaise with authorities, and support corrective actions in alignment with FDA, ISO, and other global standards.Key Responsibilities:Develop and maintain procedures for recalls, MDR/MPR, and complaint handling.Lead the preparation and submission of MDRs, MPRs, recalls, and FSCAs.Serve as the SME during regulatory audits and inspections.Maintain effective communication with internal teams and external stakeholders.Ensure accurate and timely regulatory submissions and documentation.Prepare and coordinate customer notifications and field corrections.Collaborate with global regulatory teams and support regulatory authority interactions (FDA, Health Canada, etc.).Oversee corrections, removals, and recalls.Drive investigations and trend analysis for critical complaints.Generate statistical reports to identify systemic issues.Qualifications:5–8 years of experience in the life sciences industry, preferably medical devices.Bachelor's degree in a scientific or healthcare-related field (preferred).Demonstrated expertise in medical device recalls, MDRs, and complaint handling.Strong regulatory writing and submission experience.Familiarity with FDA regulations (21 CFR 803, 806, 820, 830) and ISO 13485/14971.Experience with FDA eSubmitter and ESG platforms.Solid understanding of Quality Management Systems in regulated environments.Seniority levelSeniority levelAssociateEmployment typeEmployment typeFull-timeJob functionJob functionLegal and Quality AssuranceIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at ACE Partners by 2xInferred from the description for this jobMedical insuranceVision insurance401(k)Pension planPaid maternity leaveChild care supportPaid paternity leaveDisability insuranceGet notified when a new job is posted.Sign in to set job alerts for "Regulatory Specialist" roles.Trade Compliance Manager – Regulatory Affairs – Charlotte, NC (Hybrid)Charlotte, NC $110,000.00-$140,000.00 1 week agoFort Mill, SC $9,679.00-$12,099.00 1 day agoQuality Assurance Specialist, Document ControlRegulatory Compliance, Centralized Licensing LeadCharlotte, NC $110,000.00-$180,000.00 2 weeks agoCharlotte, NC $110,000.00-$125,000.00 1 day agoCompliance Regulatory Inventory Manager (US)Apparel Quality Specialist - Part Time - GW LoSoBusiness Line Regulatory Review Manager - Institutional Client GroupCharlotte, NC $126,820.00-$149,200.00 1 week agoSenior Director of Regulatory Operations, 2 Hour Learning (Remote) - $400,000/year USDDCXM Audit and Regulatory Planning/Execution LeaderCharlotte, NC $74,000.00-$83,641.00 1 week agoSyndicated Loan Closing Specialist - CIBApparel Quality Specialist-Indian Land-Part TimeCharlotte, NC $67,500.00-$85,400.00 13 hours agoField Specialist, Environmental Health and Safety - Concord, NCApparel Quality Specialist-Shopton-Part TimeApparel Quality Specialist - Part time - HuntersvilleWe're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.J-18808-Ljbffr