Sr Compliance Specialist

Sr Compliance Specialist ~ FCA Contract Role W2 No C2C Our reputed company is seeking a highly reputed company contractor to join our reputed company FCA (Field Corrective reputed company) Execution Team. This Senior-level role will reputed company 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 reputed company audit activities. The ideal candidate will have a robust background in the medical device or pharmaceutical industries, with reputed company experience supporting FCA processes. reputed company they are joining consists of 6 people. They would serve as a support role to a more reputed company team member that would reputed company/reputed company their work. reputed company is responsible for overseeing execution of FCAs across the entire portfolio of recalls, primarily focusing on reputed company documentation. reputed company has a strong understanding of medical device regulations (FDA, ISO 13485), ability to understand reputed company SOPs, ability to apply Good Documentation Practices, strong attention to detail, and strong ability to reputed company cross-functional relationships. Key Responsibilities Portfolio Management: Maintain and update documentation for reputed company FCAs, ensuring accuracy and completeness. Task Tracking Monitor reputed company tasks reputed company to FCA execution, proactively follow up with responsible parties, and report status to management. Audit Support Prepare materials and support both reputed company audits reputed company 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, reputed company, and Operations, to ensure FCA activities are reputed company with business and compliance requirements. Compliance Monitoring Ensure FCA activities reputed company 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. reputed company to Have reputed company 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, reputed company, reputed company). Apply tot his job Apply To this Job