Sr. Regulatory Affairs Specialist

Job Summary This critical consulting assignment drives global regulatory compliance and market expansion for innovative medical device technologies. Acting as the Regulatory Affairs Lead, the specialist ensures robust technical documentation alignment with evolving international standards, directly accelerating the delivery of safe, effective therapeutic solutions to global healthcare markets. This is a one-year engagement offering remote flexibility with a strong preference for candidates capable of aligning with operations in Memphis, TN. Location: Cordova, Tennessee. Job type: Contract. Salary: $37.00 – $39.86 per hour. Work hours: 9 to 5. Education required: Bachelor's degree. Responsibilities Global Submissions Management: Lead the independent preparation, review, and execution of complex regulatory submissions, including US FDA 510(k) notifications and EU MDR technical documentation, ensuring seamless market access. Strategic Lifecycle Leadership: Serve as the primary Regulatory Affairs representative on cross‑functional project teams, establishing comprehensive regulatory strategies, testing requirements, and compliance pathways to meet critical commercial launch timelines. Change Assessment & Compliance: Initiate and execute detailed regulatory change assessments for product designs, labeling alterations, and manufacturing process modifications to determine global registration impact and maintain continuous compliance. Quality Systems & SOP Optimization: Develop, maintain, and refine company Standard Operating Procedures (SOPs) to guarantee strict alignment with shifting global regulatory frameworks and international quality standards. Audit Readiness & Agency Engagement: Plan, support, and lead internal and external regulatory agency audits, directing engagement with regulatory authorities as required. Cross‑Functional Mentorship: Provide technical guidance, regulatory interpretation, and compliance training to engineering, quality, and clinical development teams. Qualifications Required Education & Experience: Bachelor's degree in a scientific, engineering, or technical discipline (or equivalent professional experience). Required Industry Expertise: Minimum of 3–5 years of dedicated regulatory affairs experience within the medical device sector, demonstrating a successful track record of commercial clearances in major global markets. Required Technical Proficiencies: Direct experience utilizing Product Lifecycle Management (PLM) systems and managing regulatory workflows within a highly matrixed, diverse team environment. Preferred Qualifications: Specialized expertise in authoring EU MDR technical documentation and a comprehensive understanding of US FDA 510(k) submission pathways. Skills: Regulatory Affairs Operations, Regulatory Affairs Strategy, SOP Development, Global Regulatory Strategy Execution. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. Benefits: Medical, prescription, dental, vision, AD&D, and life insurance offerings; short‑term disability; 401(k) plan (all benefits based on eligibility). #J-18808-Ljbffr