Regulatory Affairs Specialist- Remote

Overview MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with medical, scientific, and organ and tissue donation communities. Shift: Monday through Friday 8:15am to 4:30pm. Hybrid position must be able to commute to Edison, NJ and Jessup, PA. Salary Range: $80,000-$96,000/yr. Responsibilities Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Utilize this understanding to develop clear procedures for the organization. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Act as a liaison between the organization and state, local, federal, and international agencies, communicating on pre‑submission strategies, potential regulatory pathways, compliance test requirements, and clarification and follow‑up of submissions under review. Participate as a member of project teams to ensure Design Control, Risk Management, and Release to Market activities are in compliance with appropriate standards/regulations. Coordinate, prepare, and review documentation for international and domestic submissions to FDA, Health Canada, and other international regulatory agencies. Strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs. Advise project teams on export and labeling requirements, pre‑market regulatory requirements, and clinical study compliance issues. Provide documentation in response to outside inquiries relating to Good Tissue Practices/Good Manufacturing Practices. Participate in internal or external audits. Review and approve MTF labeling and finished good specifications, as well as the marketing literature of business partners. Create, review, and update Design History Files (DHFs) and Device Master Records (DMRs), and conduct periodic audits to ensure compliance with MTF Design Control procedures. Provide technical support during product recalls. Assist on special projects and perform additional duties as assigned. Qualifications Bachelor's degree in science or a related field. Three years of experience in an FDA‑regulated field. Knowledge of GTPs/GMPs. Ability to work on project teams. Strong communication, organizational, and time‑management skills, including technical writing. Proficient in Microsoft Office. Benefits 4 weeks Paid Time Off (PTO) Paid holidays Medical, dental, vision, and prescription drug insurance 401(k) plan with company match Short and long‑term disability Life and accidental death insurance Tuition reimbursement Health Care/Dependent Care Flexible Spending Accounts Adoption assistance Voluntary benefits (e.g., pet insurance, legal, home and auto insurance) Sword Health (at‑home physical therapy) #J-18808-Ljbffr MTF Biologics