Jobs at axogen

Supports enterprise financial planning and analysis, including rolling forecasts, annual budgets, long-range planning, management reporting, variance analysis, workforce and capital planning, cash flow forecasting, and financial modeling. Partners with business leaders, HR, Analytics, and Data teams to improve forecast accuracy, reporting, data quality, and FP&A processes. Prepares executive and Board reporting, performs scenario and investment analyses, and serves as a Planful power user.

Manages quality assurance operations, quality management systems, regulatory compliance, audits, risk assessments, investigations, validation, and continuous improvement for tissue, biologic, and medical device products. Leads QA teams, supports GMP processing and distribution operations, oversees cleanroom and facility quality activities, develops quality metrics, and serves as a regulatory and quality systems subject matter expert.

Leads quality engineering and compliance activities for medical device, biologic, and human tissue products. Responsibilities include design controls, risk management, validation, quality planning, statistical analysis, inspection planning, supplier quality, nonconformance resolution, audits, regulatory compliance, and continuous improvement. The role collaborates across product development, manufacturing, clinical, supply chain, and other functions, may supervise staff, and requires travel up to 30%.

Manage the GxP Supplier Quality Management program, including supplier audits, quality agreements, approved supplier qualification, performance metrics, controlled documents, change assessments, training, and inspection readiness. Ensure compliance with FDA, EMA, Health Canada, ISO, ICH, 21 CFR, and other applicable requirements. Provide quality oversight for contract service providers and support cross-functional improvement initiatives and regulatory inspections.

Manage Axogen’s quality complaint system and serve as a principal complaint investigator. Responsibilities include complaint investigations, trending, timely closure, regulatory reporting, FDA and notified-body interactions, adverse-event and pharmacovigilance coordination, controlled-document approval, personnel training, senior-management reporting, and inspection support. The role requires applying medical device and pharmaceutical regulations, risk-management principles, and cross-functional collaboration with Quality Engineering, Medical Affairs, and Regulatory Affairs.

Axogen is accepting resumes for its internship talent community. Candidates who do not find a currently suitable internship may share their resume and background to be considered for future internship opportunities. The company highlights a supportive culture, professional growth, healthcare-focused mission, comprehensive benefits, educational assistance, retirement matching, paid holidays, and other employee programs.

Axogen invites candidates to join its corporate talent community for consideration for future opportunities. Applicants are encouraged to submit a resume and information about their background. The company highlights its mission, culture, benefits, professional growth opportunities, healthcare-related compliance requirements, and equal employment practices.

Manages Axogen’s complaint system as the principal investigator and system performance owner. Leads tissue, biologics, and medical device complaint investigations; prepares HHEAs, FARs, and MDRs; coordinates with FDA and other regulators; monitors complaint trends, closure timeliness, and reporting compliance; coordinates adverse-event determinations; maintains controlled documents; trains personnel; reports program status to senior management; and supports regulatory and notified-body inspections.

Lead market development for head & neck specialty to drive surgeon adoption and change standards of care. Develop strategy, integrated marketing programs, KOL and society engagement, analytics and KPIs, and commercial enablement. Build and mentor a high‑performing team while aligning cross‑functional stakeholders to accelerate product adoption and reimbursement.

Lead end-to-end product development for peripheral nerve repair devices from concept through commercialization. Design and execute studies, generate prototypes, perform V&V, manage risk and regulatory design controls, collaborate cross-functionally, document findings, and mentor junior engineers to ensure compliant, high-quality product outcomes.

Support material flow in a cGMP processing center: receive, store, pick, ship, and deliver materials; maintain FIFO, inventory accuracy, documentation, safety, and cleanroom compliance. Assist training, participate in continuous improvement, and perform physical warehouse duties including lifting and shift coverage.

The Director of Market Development leads strategies that drive growth and adoption in medical devices, enhancing brand perception and changing clinical behaviors. Responsibilities include market research, executing integrated marketing programs, and engaging key opinion leaders.

Lead a regional sales organization for peripheral nerve repair products by setting territory targets, coaching reps, managing inventory and budgets, analyzing sales/market trends, presenting business plans, ensuring compliance, and driving adoption through training and field development across a Southeast territory.