VIVEX Biologics
201 - 500 employees
VIVEX develops and delivers innovative allografts designed to support the body’s healing potential to help improve patient outcomes and quality of life. Our medical technologies date back 50 years to the founding of The University of Miami Tissue Bank in 1970. Since that time, we have experienced multiple firsts in clinical and scientific achievements. VIVEX’s strategic plan is focused on the development of new innovative allografts, research and development, enhancement of manufacturing capabilities, and sales and marketing efforts.
Director of Regulatory Affairs
🕒 June 2
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VIVEX Biologics
201 - 500 employees
VIVEX develops and delivers innovative allografts designed to support the body’s healing potential to help improve patient outcomes and quality of life. Our medical technologies date back 50 years to the founding of The University of Miami Tissue Bank in 1970. Since that time, we have experienced multiple firsts in clinical and scientific achievements. VIVEX’s strategic plan is focused on the development of new innovative allografts, research and development, enhancement of manufacturing capabilities, and sales and marketing efforts.
📋 Description
• Responsible for the coordination, compilation and submission of biologics and medical device applications. • Develop and implement Chemical and Manufacturing Controls (CMC). • Provide guidance to project teams on the regulatory framework from the FDA. • Manage supplier and distributor qualifications and the company’s auditing program. • Maintain voluntary accreditations, state licenses, and establishment registrations.
🎯 Requirements
• Bachelor of Science or Arts in a relevant discipline is required. • Minimum of 7 years Tissue Bank, Medical Device, Biologics or Pharmaceutical experience with 4 years management experience preferred. • AATB CTBS, ASQ, or other allied health licensure or certification preferred.
🏖️ Benefits
• Health insurance • Professional development opportunities
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