Sr Compliance Specialist

Sr Compliance Specialist ~ FCA Contract Role W2 No C2C Our client is seeking a highly experienced contractor to join our Enterprise FCA (Field Corrective Action) Execution Team. This Senior-level role will provide critical support in managing our FCA portfolio, including ensuring robust FCA documentation as evidence of completion of FCA activities (e.g. notifications, retrievals, software updates), identifying and reporting on risks to completing activities on-time, and supporting internal and external audit activities. The ideal candidate will have a robust background in the medical device or pharmaceutical industries, with direct experience supporting FCA processes. The team they are joining consists of 6 people. They would serve as a support role to a more experienced team member that would direct/oversee their work. The team is responsible for overseeing execution of FCAs across the entire portfolio of recalls, primarily focusing on quality documentation. The team has a strong understanding of medical device regulations (FDA, ISO 13485), ability to understand Quality SOPs, ability to apply Good Documentation Practices, strong attention to detail, and strong ability to form cross-functional relationships. Key Responsibilities Portfolio Management: Maintain and update documentation for active FCAs, ensuring accuracy and completeness. Task Tracking Monitor open tasks related to FCA execution, proactively follow up with responsible parties, and report status to management. Audit Support Prepare materials and support both internal and external audits related to FCA processes, including data gathering and response coordination. Process Improvement Identify opportunities to streamline FCA documentation and tracking processes; recommend and implement improvements. Stakeholder Collaboration Work closely with cross-functional teams, including Regulatory, Quality, and Operations, to ensure FCA activities are aligned with business and compliance requirements. Compliance Monitoring Ensure FCA activities comply with relevant regulations (FDA, EU MDR, etc.) and internal SOPs. Must Have Bachelor’s degree in a relevant field (Life Sciences, Engineering, Business, or similar). Minimum 4 years’ experience in the medical device or pharmaceutical industry. Strong project management and organizational skills; proven ability to manage multiple priorities. Excellent written and verbal communication skills. Ability to work independently and deliver results with minimal supervision. Nice to Have Direct experience managing or supporting Field Corrective Actions (FCA), recalls, or similar post-market activities. Experience supporting audits (internal, external, or regulatory). In-depth knowledge of industry regulations (FDA, EU MDR, ISO standards). Advanced proficiency in documentation and tracking tools (e.g., SharePoint, Smartsheet, Excel).