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/yr Direct message the job poster from ACE Partners Empowering the Next Generation of Vascular MedTech with Top Talent Job Title: Regulatory Specialist Overview: 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 level Seniority level Associate Employment type Employment type Full-time Job function Job function Legal and Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at ACE Partners by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Pension plan Paid maternity leave Child care support Paid paternity leave Disability insurance Get 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 ago Fort Mill, SC $9,679.00-$12,099.00 1 day ago Quality Assurance Specialist, Document Control Regulatory Compliance, Centralized Licensing Lead Charlotte, NC $110,000.00-$180,000.00 2 weeks ago Charlotte, NC $110,000.00-$125,000.00 1 day ago Compliance Regulatory Inventory Manager (US) Apparel Quality Specialist - Part Time - GW LoSo Business Line Regulatory Review Manager - Institutional Client Group Charlotte, NC $126,820.00-$149,200.00 1 week ago Senior Director of Regulatory Operations, 2 Hour Learning (Remote) - $400,000/year USD DCXM Audit and Regulatory Planning/Execution Leader Charlotte, NC $74,000.00-$83,641.00 1 week ago Syndicated Loan Closing Specialist - CIB Apparel Quality Specialist-Indian Land-Part Time Charlotte, NC $67,500.00-$85,400.00 13 hours ago Field Specialist, Environmental Health and Safety - Concord, NC Apparel Quality Specialist-Shopton-Part Time Apparel Quality Specialist - Part time - Huntersville We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr