Medical Device Regulatory Affairs Specialist - RELO - ...

**This job is in Pittsburgh***We are seeking a driven, detail-oriented Regulatory Affairs Specialist to join our growing medical device team and support regulatory submissions, compliance initiatives, and full product lifecycle management for implantable cardiovascular devices. This is a hands-on role for a motivated professional who excels in highly regulated environments, collaborates effectively across technical and clinical teams, and takes true ownership of their work. If you have a strong working knowledge of FDA and international regulatory requirements and are looking to build a long-term career in Regulatory Affairs, we encourage you to apply.Regulatory Affairs Specialist Benefits100% top-tier employee-paid health, dental, and vision insurance401(k) with 3.5% company matchFlexible work environment with strong work/life balance20 days PTO + 5 sick daysInclusive, collaborative, and equity-focused workplaceLow-micromanagement, results-driven cultureCareer growth within a growing organizationRegulatory Affairs Specialist QualificationsBachelor’s degree in Engineering (Biomedical), Life Sciences, Regulatory Affairs, or related field3-5 years of experience in medical device regulatory affairsWorking knowledge of FDA 21 CFR, ISO 13485, EU MDR, and design controlsExperience supporting US and international regulatory submissionsStrong technical writing and documentation skillsHigh attention to detail and strong organizational abilitiesComfortable working independently in a fast-paced environmentExperience with cardiovascular or implantable devices preferredFamiliarity with export/import regulations and eQMS systems is a plusRegulatory Affairs Specialist Responsibilities IncludeSupport regulatory pathways for new product introductions and design changesAssist in preparing and organizing US and international regulatory submissionsContribute to filing strategies, testing requirements, and standards alignmentMaintain regulatory records, procedures, and submission archivesSupport compliance with FDA, ISO, and international regulationsAssist with product registrations, renewals, and regulatory commitmentsPartner with Engineering, Quality, Manufacturing, and R&D to gather technical documentationParticipate in design reviews and risk management activitiesProvide regulatory input on labeling, testing, and change managementSupport internal and external audits and regulatory inspectionsAssist with inspection preparation and agency responsesMonitor regulatory changes and communicate potential impactsSupport export and import compliance requirementsHelp resolve regulatory challenges using compliant, practical solutionsContribute to the continuous improvement of regulatory systems and workflows

Created: 2026-02-04