Director of Regulatory Affairs

Description The Director of Regulatory Affairs will be responsible for coordination, compilation and submission of biologics and medical device applications, as well as other submissions to regulatory agencies. This person will develop and implement Chemical and Manufacturing Controls (CMC). They will also provide guidance to project teams on FDA regulatory framework to add value to the commercialization of medical products. Additionally, the Director will manage supplier and distributor qualifications, the company’s auditing program, maintain voluntary accreditations, state licenses, and establishment registrations and listings. Duties and Responsibilities Provide regulatory guidance to Marketing and the management team on requirements related to advertising, promotion, labeling, corporate and public communications and materials. Manage supplier and distributor qualifications and the organization’s internal and external auditing program. Work with multidisciplinary teams on commercialization to ensure compliance with FDA regulations, including: Coordinating, compiling, and submitting regulatory filings such as Requests for Designation (RFD), Investigational New Drug (IND), Biologics License Application (BLA), 510(k), and Pre‑Market Approval (PMA). Developing and implementing CMC. Supporting clinical trial protocol development. Overseeing and maintaining licensing, registration, and accreditation with state, federal, and independent regulatory bodies. Supporting and maintaining regulatory reporting initiatives, including MedWatch and Biological Product Deviations. Staying current on industry trends and practices, participating in association memberships or committees, identifying patterns to improve processes, and assisting in policy and procedure development across all business aspects. Performing other related duties as assigned. Qualifications Education: Bachelor of Science or Arts in a relevant discipline. Experience: Minimum 7 years in Tissue Bank, Medical Device, Biologics, or Pharmaceutical fields with 4 years management experience preferred. Licenses/Certifications: AATB, CTBS, ASQ, or other allied health licensure or certification preferred. Working Conditions Office, processing plant work, and travel by air, train, and car. Some evening and weekend work may be required. Physical Requirements Regularly required to sit; may need to stand for prolonged periods. Occasionally required to pull, lift, or move up to 20 pounds. Direct Reports Regulatory Affairs Manager, Audit Program Supervisor Equal Opportunity Employer Vivex Biologics, Inc. is an equal‑opportunity employer (EEO) and prohibits discrimination or harassment based on race, color, religion, gender, sexual orientation, gender identity, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absence, compensation, and training. Compliance with the Americans with Disabilities Act Vivex Biologics, Inc. complies with the ADA, which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of the job. #J-18808-Ljbffr