Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager Location: On-site in Edina, MN*No sponsorships available for this rolePosition SummaryThe Regulatory Affairs Manager is responsible for leading and executing the organization’s regulatory strategy to ensure compliance with applicable FDA, EPA, and ISO 13485 requirements. This role provides regulatory leadership across the full product lifecycle, supporting both manufacturing and commercial operations, and serves as the primary regulatory interface with external agencies.The ideal candidate brings 5–10 years of progressive regulatory experience, a strong understanding of regulated quality systems, and the ability to partner cross-functionally to enable compliant growth.Essential Duties and ResponsibilitiesRegulatory Leadership & SubmissionsLead and manage FDA regulatory submissions, including product registrations, listings, and applicable premarket submissions (e.g., 510(k), De Novo, EUA, as required).Manage EPA regulatory submissions, including registrations, amendments, renewals, and associated compliance activities.Develop and maintain regulatory strategies aligned with business objectives and product commercialization plans.Serve as the primary point of contact with regulatory authorities, including FDA and EPA.Quality System & ISO 13485 ComplianceEnsure ongoing compliance with ISO 13485 and applicable FDA Quality System Regulations (21 CFR 820 / QMSR).Collaborate with Quality Assurance to maintain and continuously improve the Quality Management System.Review and approve controlled documents, change controls, validations, and risk management activities to ensure regulatory compliance.Provide regulatory input into CAPA investigations, nonconformance management, and corrective action plans.Audit & Inspection ManagementLead regulatory activities during internal and external audits, including:FDA inspectionsISO 13485 certification auditsCustomer and third-party auditsPrepare the organization for regulatory inspections through readiness activities and internal assessments.Lead the development and execution of responses to audit observations and regulatory findings.Cross-Functional PartnershipPartner with Manufacturing, Engineering, Quality, R&D, and Supply Chain to ensure regulatory compliance throughout production and process changes.Collaborate with Commercial, Marketing, and Sales teams to review and approve labeling, promotional materials, and product claims.Provide regulatory guidance during product development, technology transfer, and commercialization activities.Leadership & CommunicationAct as a regulatory subject matter expert and advisor to senior leadership.Establish and maintain scalable regulatory processes and procedures.Support training initiatives to ensure organizational awareness of regulatory requirements.Qualifications:RequiredBachelor’s degree in a scientific, engineering, or related discipline.5–10 years of regulatory affairs experience within FDA-regulated industries.Demonstrated expertise in:ISO 13485FDA medical device regulations (21 CFR 820 / QMSR)FDA submission processes and lifecycle managementEPA regulatory compliance and submissionsProven experience leading regulatory audits and inspections.Strong written and verbal communication skills.PreferredExperience in medical devices, diagnostics, or regulated manufacturing environments.Experience supporting products regulated by both FDA and EPA.RAC or comparable professional certification.Experience operating in a cross-functional, matrixed organization.Key CompetenciesRegulatory strategy and executionAudit and inspection leadershipCross-functional collaborationRisk-based decision makingAttention to detail and documentation rigorProfessional judgment and discretion