Regulatory Affairs Specialist

Regulatory Affairs SpecialistThis role is ideal for a regulatory professional with strong experience in FDA, Health Canada, and EU medical device requirements. The Regulatory Affairs Specialist will maintain global registrations and technical documentation, support audits, manage product compliance throughout the lifecycle, and provide strategic regulatory input to cross-functional teams.Key ResponsibilitiesMaintain and update European technical files, including risk assessments, usability reports, and clinical evaluationsPrepare and execute annual regulatory registrations for the U.S. (FDA), Canada, and other global marketsAssist international distributors with product registration and compliance requirementsReview product changes to ensure ongoing regulatory conformityEvaluate product labeling, marketing content, and advertising materials for complianceSupport and manage product recalls, adverse event reporting (MDR/Vigilance), and regulatory communicationsLead and support regulatory audits and inspections by the FDA, Notified Bodies, and customersPrepare change notifications for submission to global regulatory authoritiesDraft, revise, and maintain SOPs related to regulatory processesMaintain regulatory certificates including the Certificate to Foreign Government (CFG)Respond to customer surveys, internal requests, and other ad hoc regulatory needsCollaborate with Quality, R&D, and Manufacturing to maintain compliance across the product lifecycleOther duties as assignedRequired QualificationsBachelor's degree in a scientific, technical, or regulatory disciplineMinimum 3 years' experience in Regulatory Affairs within an FDA-registered and ISO-certified medical device companyHands-on experience with: Technical files and global registrationsMedical Device Reporting (MDR)Vigilance and recall managementChange control and agency notificationsWorking knowledge of: FDA 21 CFR Part 820ISO 13485Health Canada and European medical device regulations (including MDR)ISO 14971 and MDSAPStrong organizational and time-management skills with keen attention to detailClear and professional written and verbal communication skillsAble to work independently and take ownership of assigned responsibilitiesFamiliarity with sterilization processes (EO and Gamma) is strongly preferredProficiency with Microsoft Office Suite