Regulatory Affairs Specialist

Work with product development and manufacturing management to ensure product development meets applicable regulatory requirements Participate as a member of project teams Approve labeling, marketing literature, and finished good specifications Maintain current knowledge of regulations, standards, and guidance documents and develop organizational procedures Technically review data and reports for regulatory submissions Liaise with state, local, federal, and international agencies regarding submission strategies, regulatory pathways, testing requirements, and submission follow-up Ensure Design Control, Risk Management, and Release to Market activities comply with applicable standards and regulations Coordinate, prepare, and review domestic and international submissions to the FDA, Health Canada, and other international regulatory agencies Balance regulatory concerns, marketing objectives, time to market, technology, compliance, and costs Advise project teams on export and labeling requirements, premarket regulatory requirements, and clinical study compliance Provide documentation in response to Good Tissue Practices/Good Manufacturing Practices inquiries Participate in internal and external audits Review and approve MTF labeling, finished good specifications, and business-partner marketing literature Create, review, and update Design History Files and Device Master Records and conduct periodic compliance audits Provide technical support during product recalls Assist on special projects and perform additional duties as assigned Requirements Bachelor's degree in science or a related field 3 years experience in an FDA regulated field Knowledge of GTPs/GMPs Ability to work on project teams Strong communication, organizational and time management skills Technical writing skills Proficient in Microsoft Office Must be able to commute to Edison, NJ and Jessup, PA Standard business hours: Monday through Friday, 8:15am to 4:30pm EST Core Competencies Demonstrates expertise in regulatory compliance, including FDA and Health Canada submissions, while effectively collaborating with project teams to balance regulatory requirements with marketing objectives. Proficient in technical writing and maintaining compliance documentation, ensuring adherence to Good Tissue Practices and Good Manufacturing Practices. Highest-signal resume keywords Regulatory Submissions FDA Compliance Good Tissue Practices Technical Writing Project Team Collaboration Hard Skills Regulatory Compliance Technical Review Design Control Risk Management Documentation Management Labeling Approval Data Analysis Compliance Audits Submission Strategies Device Master Records Soft Skills Strong Communication Organizational Skills Time Management Team Collaboration Problem Solving Industry Keywords FDA Regulations Health Canada Good Manufacturing Practices Clinical Study Compliance Export Requirements Tools & Technologies Microsoft Office #J-18808-Ljbffr Jobtailor