Vericel® Corporation

Compliance

• Independently plan, prioritize, and manage regulatory activities across assigned development and commercial products
• Develop and implement regulatory strategies supporting timely approvals, continued compliance, and company objectives
• Manage assembly and timely submission of INDs, BLAs, and other dossiers for biologics investigation and registration
• Assess priorities, identify regulatory risks and opportunities, make recommendations, and escalate significant issues with proposed solutions or mitigation plans
• Respond to changing regulatory requirements, health authority requests, emerging product issues, and shifting business priorities
• Maintain regulatory submissions in compliance with regulatory requirements
• Represent the company in dealings with the FDA and other regulatory authorities
• Serve as regulatory lead or subject-matter expert on cross-functional project teams
• Provide guidance across products, regulatory pathways, biologics, and combination products
• Maintain current regulatory knowledge and advise management of significant developments
• Contribute to improvements involving best practices and SOPs
• Interface with departments, CROs, and external vendors as needed
• Reports to the Director, Regulatory Affairs

Senior Manager, Regulatory Affairs

Logistics Specialist

• Manage and continuously improve commercial logistics operations supporting Vericel’s Burn and Cartilage Care franchises
• Own final product delivery logistics, surgical instrument and consignment programs, logistics vendors, and related systems
• Collaborate with Supply Chain, Manufacturing, Operations, Sales Leadership, Finance, external vendors, and Vericel UK
• Establish and monitor logistics performance measures and lead process improvements
• Plan final delivery of MACI implants and Epicel grafts
• Coordinate weekly transport of MACI patient lots from Vericel and two specialty pharmacies
• Provide accurate airwaybills to QA and adjust schedules or pickup times with Operations and couriers
• Monitor shipments and triage delays, losses, and last-minute changes
• Communicate delivery changes with specialty pharmacies and significant delays with Sales and Sales Leadership
• Integrate the logistics platform with Salesforce CRM to improve visibility and analytics
• Manage logistics vendor performance and spend, identify cost-saving opportunities, and establish service expectations
• Manage the surgical tray consignment program, including quarterly audits and inventory levels based on forecasts
• Manage the Move Medical arthroscopic instrument inventory platform
• Enhance SOPs for sales teams, Supply Chain, Sales Operations, and instrument manufacturing
• Conduct quarterly audits of field trunk stock and manage home-office inventory for surgeon training
• Support development and commercialization of sellable surgical trays and durable and single-use instruments for U.S. and UK markets
• Design and manage instrument sales processes with Sales, Supply Chain, and Finance
• Support pricing implementation and Value Analysis Committee requirements

Senior Manager, Regulatory Affairs

Senior Specialist, Commercial Logistics