Regulatory Manager

At Safecor Health, our mission is simple but powerful: help hospitals deliver medications safely, efficiently, and reliably.As the nation’s largest independently owned medication repackaging company, we support over 1,000 hospitals and healthcare systems across the country. Behind every unit-dose product is a team driven by our core values:Care Commitment ExcellenceWe’re looking for a Manager, Quality Assurance & Regulatory to lead critical quality and regulatory initiatives that ensure our products meet the highest standards—and ultimately protect patient safety.The OpportunityThis is a high-impact leadership role responsible for shaping and maintaining FDA-compliant Quality Systems, driving regulatory strategy, and ensuring operational excellence across our organization.You’ll partner across teams, influence key decisions, and play a vital role in keeping Safecor in a constant state of compliance and readiness.What You’ll DoLead and maintain FDA-compliant Quality Systems (21 CFR Parts 210, 211, 820, 11, and 4)Drive quality strategy, ensuring consistent production aligned with regulatory standardsOversee vendor qualification programs, including audits and evaluationsLead regulatory activities, including FDA/DEA interactions and field actionsManage and enhance stability programs, including coordination with external labsProvide quality oversight for contract packaging and outsourcing programsLead responses to FDA inspections, audits, and customer inquiriesEnsure labeling compliance and regulatory submissions (e.g., SPL, CARES Act reporting)Oversee change control, deviations, CAPAs, and batch record review/releaseDrive continuous improvement through regulatory intelligence and quality system enhancementsPartner cross-functionally and across sites to strengthen quality processesWhat You BringWhat You BringBachelor’s degree in a scientific field (or equivalent experience)5+ years in pharmaceutical or medical device industry, with regulatory experienceProven experience with FDA regulations and Quality Systems developmentLeadership experience managing people and/or complex processesExperience supporting or leading FDA inspections and auditsStrong knowledge of ICH guidelines, DEA regulations (preferred), and cGMP environmentsExceptional communication, organization, and problem-solving skillsA proactive, solutions-oriented mindset with a drive for continuous improvementWhy Safecor Health?At Safecor, you’re not just maintaining compliance—you’re helping ensure that patients receive medications safely when they need them most.You’ll be part of a team that:Cares deeply about patients and each otherIs committed to doing the right thingStrives for excellence in everything we doReady to Make an Impact?If you’re passionate about quality, regulatory excellence, and making a real difference in healthcare—we’d love to hear from you.